<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03004924</url>
  </required_header>
  <id_info>
    <org_study_id>SHP640-303</org_study_id>
    <secondary_id>2016-003361-25</secondary_id>
    <nct_id>NCT03004924</nct_id>
  </id_info>
  <brief_title>Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo</brief_title>
  <official_title>A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if an investigational treatment is effective&#xD;
      compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial&#xD;
      conjunctivitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5</measure>
    <time_frame>Day 5</time_frame>
    <description>Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5</measure>
    <time_frame>Baseline, Day 5</time_frame>
    <description>Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Resolution</measure>
    <time_frame>Day 3, 8 and 12</time_frame>
    <description>Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Bacterial Eradication</measure>
    <time_frame>Day 3, 8 and 12</time_frame>
    <description>Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bulbar Conjunctival Injection Score</measure>
    <time_frame>Day 3, 5, 8 and 12</time_frame>
    <description>Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Bulbar Conjunctival Injection Score</measure>
    <time_frame>Baseline, Day 3, 5, 8 and 12</time_frame>
    <description>Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular Conjunctival Discharge Score</measure>
    <time_frame>Day 3, 5, 8 and 12</time_frame>
    <description>Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Ocular Conjunctival Discharge Score</measure>
    <time_frame>Baseline, Day 3, 5, 8 and 12</time_frame>
    <description>Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Clinical Score</measure>
    <time_frame>Day 3, 5, 8 and 12</time_frame>
    <description>Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Global Clinical Score</measure>
    <time_frame>Baseline, Day 3, 5, 8 and 12</time_frame>
    <description>Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Modified Clinical Resolution</measure>
    <time_frame>Day 3, 5, 8 and 12</time_frame>
    <description>Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Expanded Clinical Resolution</measure>
    <time_frame>Day 3, 5, 8 and 12</time_frame>
    <description>Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical Resolution</measure>
    <time_frame>Baseline to Day 12</time_frame>
    <description>Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Used Rescue Medication</measure>
    <time_frame>Baseline to Day 12</time_frame>
    <description>Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From start of study drug administration up to 14 days</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">753</enrollment>
  <condition>Bacterial Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>SHP640</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will instill 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PVP-I 0.6%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHP640</intervention_name>
    <description>Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.</description>
    <arm_group_label>SHP640</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PVP-I 0.6%</intervention_name>
    <description>Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.</description>
    <arm_group_label>PVP-I 0.6%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An understanding, ability, and willingness to fully comply with study procedures and&#xD;
             restrictions (by the parent(s), guardian, or legally authorized representative, if&#xD;
             applicable).&#xD;
&#xD;
          -  Ability to voluntarily provide written, signed, and dated (personally or via a&#xD;
             parent(s), guardian, or legally authorized representative(s) informed consent (and&#xD;
             assent, if applicable) to participate in the study.&#xD;
&#xD;
          -  Participants of any age at Visit 1 (Note: participants less than (&lt;) 3 months of age&#xD;
             at Visit 1 must have been full-term, that is (ie,) greater than or equal to (&gt;=) 37&#xD;
             weeks gestational age at birth).&#xD;
&#xD;
          -  Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.&#xD;
&#xD;
          -  Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye&#xD;
             confirmed by the presence of the following minimal clinical signs and symptoms in that&#xD;
             same eye:&#xD;
&#xD;
               1. Report presence of signs and/or symptoms of bacterial conjunctivitis for less&#xD;
                  than or equal to (&lt;=) 4 days prior to Visit 1&#xD;
&#xD;
               2. Bulbar conjunctival injection: a grade of &gt;= 1 on 0-4 scale of Bulbar&#xD;
                  Conjunctival Injection Scale&#xD;
&#xD;
               3. Ocular conjunctival discharge: a grade of &gt;= 1 (mild) on a 0-3 scale of Ocular&#xD;
                  Conjunctival Discharge Scale&#xD;
&#xD;
          -  Be willing to discontinue contact lens wear for the duration of the study.&#xD;
&#xD;
          -  Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as&#xD;
             measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will&#xD;
             be assessed by an age appropriate method in accordance with the AAP Policy Statement&#xD;
             for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians&#xD;
             (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement&#xD;
             recommends formal vision screening can begin at 3 years of age. VA measurements for&#xD;
             children under the age of 3 will be done at the discretion of the investigator. If not&#xD;
             done, child should be able to fixate on and follow a moving object, except&#xD;
             participants &lt; 2 months of age who have not yet developed this ability. Participants &lt;&#xD;
             2 months will be enrolled at the discretion of investigator.&#xD;
&#xD;
          -  Male, or non-pregnant, non-lactating female who agrees to comply with any applicable&#xD;
             contraceptive requirements of the protocol or females of non-childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or recurrent disease that could affect the action, absorption, or disposition&#xD;
             of the investigational product, or clinical or laboratory assessments, per&#xD;
             investigator's discretion.&#xD;
&#xD;
          -  Current or relevant history of physical or psychiatric illness, any medical disorder&#xD;
             that may make the participant unlikely to fully complete the study, or any condition&#xD;
             that presents undue risk from the investigational product or procedures.&#xD;
&#xD;
          -  Have known or suspected intolerance or hypersensitivity to the investigational&#xD;
             product, closely related compounds, or any of the stated ingredients.&#xD;
&#xD;
          -  Prior enrollment in a FST-100 or SHP640 clinical study.&#xD;
&#xD;
          -  Participants who are employees, or immediate family members of employees (who are&#xD;
             directly related to study conduct), at the investigational site.&#xD;
&#xD;
          -  Have a history of ocular surgical intervention within &lt;= 6 months prior to Visit 1 or&#xD;
             planned for the period of the study.&#xD;
&#xD;
          -  Have a preplanned overnight hospitalization during the period of the study.&#xD;
&#xD;
          -  Have presence of any intraocular, corneal, or conjunctival ocular inflammation&#xD;
             (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis),&#xD;
             other than bacterial conjunctivitis.&#xD;
&#xD;
          -  Have active or a history of ocular herpes.&#xD;
&#xD;
          -  Have at enrollment or within &lt;= 30 days of Visit 1, a clinical presentation more&#xD;
             consistent with the diagnosis of non-infectious conjunctivitis (except presumed&#xD;
             seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg,&#xD;
             viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant&#xD;
             presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is&#xD;
             not exclusionary.&#xD;
&#xD;
          -  Neonates or infants (ie, participants less than 12 months of age) who have suspected&#xD;
             or confirmed (based on the result of any test conducted prior to screening)&#xD;
             conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.&#xD;
&#xD;
          -  Neonates or infants (ie, participants less than 12 months of age) whose birth mothers&#xD;
             had any sexually transmitted disease within 1 month of delivery or any history of&#xD;
             genital herpes.&#xD;
&#xD;
          -  Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).&#xD;
&#xD;
          -  Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity,&#xD;
             congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic&#xD;
             involvement that could affect study variables.&#xD;
&#xD;
          -  Be a known intraocular pressure (IOP) steroid responder, have a known history or&#xD;
             current diagnosis of glaucoma or be a glaucoma suspect.&#xD;
&#xD;
          -  Have any known clinically significant optic nerve defects.&#xD;
&#xD;
          -  Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary&#xD;
             to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect&#xD;
             or any significant corneal opacity at Visit 1.&#xD;
&#xD;
          -  Presence of significant, active condition in the posterior segment that requires&#xD;
             invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor&#xD;
             inhibitors or corticosteroids) and may progress during the study participation period.&#xD;
&#xD;
          -  Have used any topical ocular or systemic antibiotics within &lt;= 7 days of enrollment.&#xD;
&#xD;
          -  Have used any topical ocular non-steroidal anti-inflammatory drugs within &lt;= 1 day of&#xD;
             enrollment.&#xD;
&#xD;
          -  Have used any topical ophthalmic steroids in the last &lt;= 14 days.&#xD;
&#xD;
          -  Have used any systemic corticosteroid agents within &lt;= 14 days of Day 1. Stable&#xD;
             (initiated &gt;= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is&#xD;
             allowed, given no anticipated change in dose for the duration of the study. Topical&#xD;
             dermal steroids are allowed except in the periocular area.&#xD;
&#xD;
          -  Have used non-corticosteroid immunosuppressive agents within &lt;= 14 days of Day 1.&#xD;
&#xD;
          -  Have used any topical ophthalmic products, including tear substitutes, and&#xD;
             over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be&#xD;
             unable to discontinue all topical ophthalmic products for the duration of the study.&#xD;
             Use of hot or cold compresses is also not permitted during the study.&#xD;
&#xD;
          -  Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled&#xD;
             systemic disease or debilitating disease (eg, cardiovascular disease, hypertension,&#xD;
             sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may&#xD;
             affect the study parameters, per investigator's discretion.&#xD;
&#xD;
          -  Any known history of immunodeficiency disorder or known active conditions predisposing&#xD;
             to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence&#xD;
             of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone&#xD;
             marrow transplantation.&#xD;
&#xD;
          -  Within 30 days prior to the first dose of investigational product:&#xD;
&#xD;
               1. Have used an investigational product or device, or&#xD;
&#xD;
               2. Have been enrolled in a clinical study (including vaccine studies) that, in the&#xD;
                  investigator's opinion, may impact this Shire-sponsored study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Eye Center</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornea and Cataract Consultants of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M&amp;M Eye Institute</name>
      <address>
        <city>Prescott</city>
        <state>Arizona</state>
        <zip>86301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwartz Laser Eye Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walman Eye Center</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Milton M. Hom, OD, FAAO</name>
      <address>
        <city>Azusa</city>
        <state>California</state>
        <zip>91702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clark S Tsai Eye Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lugene Eye Institute Inc</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mark B. Kislinger, MD, Inc.</name>
      <address>
        <city>Glendora</city>
        <state>California</state>
        <zip>91741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Eye Specialists</name>
      <address>
        <city>Hemet</city>
        <state>California</state>
        <zip>92545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeside Vision Center</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hull Eye Center</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Physicians of Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford Optical</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sok H. Nam, M.D. Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macy Eye Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Valley Eye Medical Group Inc</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bay Eye Associates, Inc.</name>
      <address>
        <city>Petaluma</city>
        <state>California</state>
        <zip>94954</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arch Health Partners</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martel Eye Medical Group</name>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shasta Eye Medical Group, Inc.</name>
      <address>
        <city>Redding</city>
        <state>California</state>
        <zip>96001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Research</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento Eye Consultants</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WCCT Global (PH 1 Unit)</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East West Eye Institute</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wolstan &amp; Goldberg Eye Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialty Eye Care</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danbury Eye Physicians and Surgeons</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Connecticut</name>
      <address>
        <city>Meriden</city>
        <state>Connecticut</state>
        <zip>06824</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Windham Eye Group</name>
      <address>
        <city>Willimantic</city>
        <state>Connecticut</state>
        <zip>06226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Associates of Manatee, LLP</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bruce A. Segal, MD, PA</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Vision</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bowden Eye &amp; Associates</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shettle Eye Research, Inc.</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millenium Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Clinical Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Research Center Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bascom Palmer Eye Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lorites Medical Group</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric &amp; Adult Research Center, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medsol Clinical Research Center</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33948</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Score Physician Alliance, LLC</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Florida Eye Institute</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Logan Ophthalmic Research, LLC</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Research Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Centers Management, Inc.</name>
      <address>
        <city>Morrow</city>
        <state>Georgia</state>
        <zip>30260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jenkins Eye Care</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saltzer Medical Group</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wohl Eye Center</name>
      <address>
        <city>Bloomingdale</city>
        <state>Illinois</state>
        <zip>60108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Eye</name>
      <address>
        <city>Lake Villa</city>
        <state>Illinois</state>
        <zip>60046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Eye Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSphere Medical Research Center, LLC</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Cornea Associates, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sabates Eye Centers</name>
      <address>
        <city>Leawood</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kannarr Eye Care</name>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <zip>66762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Eye Institute</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koffler Vision Group</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Eye Institute</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Care Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Haider Eye Care</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senior Health Services</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baker, Carl W</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeview Vision</name>
      <address>
        <city>Gretna</city>
        <state>Louisiana</state>
        <zip>70056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Associates of Northeast Louisiana dba Haik Humble Eye Center</name>
      <address>
        <city>West Monroe</city>
        <state>Louisiana</state>
        <zip>71291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Center Northeast</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts Eye and Ear Infirmary</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NECCR PrimaCare Research</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shire Call Center</name>
      <address>
        <city>Lexington</city>
        <state>Massachusetts</state>
        <zip>02421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Eye Research of Boston</name>
      <address>
        <city>Winchester</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Eye Consultants, P.A</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifelong Vision Foundation</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Silverstein Eye Centers</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moyes Eye Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekwani Vision Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Associates</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Opthalmology Consultants Ltd.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Research</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NV Eye Physicians</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellish Vision Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emil A. Stein, M.D., Ltd.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern New Jersey Eye Institute</name>
      <address>
        <city>South Orange</city>
        <state>New Jersey</state>
        <zip>07079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Farkas, Kassalow, Resnick &amp;Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fichte, Endl&amp; Elmer Eyecare</name>
      <address>
        <city>Niagara Falls</city>
        <state>New York</state>
        <zip>14304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Eye Care</name>
      <address>
        <city>Wantagh</city>
        <state>New York</state>
        <zip>11793</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oculus Research at Garner EyeCareCenter</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Branch, M.D.</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Eye Kenwood</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Eye Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Eye</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Eye Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Columbus Eye Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SkyVision Centers</name>
      <address>
        <city>Westlake</city>
        <state>Ohio</state>
        <zip>44145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Research Company*</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Clear Vision Institute</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matossian Eye Associates</name>
      <address>
        <city>Doylestown</city>
        <state>Pennsylvania</state>
        <zip>18902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philadelphia Eye Associates</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Eye Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wyomissing Optometric Center</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bluestein Custom Vision</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Regional Eye Institute</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care, PA</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Specialty Group</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville Vision Associates</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toyos Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eyeland Vision</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79934</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Eye Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Laser Vision &amp; Surgical Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Travis Eye &amp; Laser Center</name>
      <address>
        <city>Lakeway</city>
        <state>Texas</state>
        <zip>78734</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCT- Shah Research, LLC dba Discovery Clinical Trials</name>
      <address>
        <city>Mission</city>
        <state>Texas</state>
        <zip>78572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Research Institute, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R and R Eye Research, LLC.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lone Star Eye Care, P.A.</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ericksen Research &amp; Development, LLC</name>
      <address>
        <city>Clinton</city>
        <state>Utah</state>
        <zip>84015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chrysalis Clinical Research</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Institute of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emerson Clinical Research Institute</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Eye Center, Inc.</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of the Sunshine Coast Clinical Trials Centre</name>
      <address>
        <city>Sippy Downs</city>
        <state>Queensland</state>
        <zip>4556</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH - Medizinische Universitaet Wien</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - General Campus, University of Ottawa Eye Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Waterloo School of Optometry and Vision Science</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)</name>
      <address>
        <city>Tallinn</city>
        <zip>10120</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tallinn Central Hospital Eye Clinic</name>
      <address>
        <city>Tallinn</city>
        <zip>10138</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tartu University Hospital</name>
      <address>
        <city>Tartu</city>
        <zip>51010</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Limoges - Hopital Dupuytren</name>
      <address>
        <city>Limoges</city>
        <state>Haute Vienne</state>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SZTE Szemeszeti Klinika</name>
      <address>
        <city>Szeged</city>
        <state>Csongrad</state>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bugat Pal Hospital Clinexpert Gyongyos</name>
      <address>
        <city>Gyongyos</city>
        <state>Heves</state>
        <zip>3200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaposi Mór Hospital</name>
      <address>
        <city>Kaposvár</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csolnoky Ferenc Korhaz</name>
      <address>
        <city>Veszprem</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HaEmek Medical Center</name>
      <address>
        <city>Afula</city>
        <zip>18341</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam MC</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharey Zedek MC</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center-Beilinson Campus.</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Rehovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico San'Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Uno-Med</name>
      <address>
        <city>Krakow</city>
        <state>Malopolska</state>
        <zip>31-070</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny nr 1</name>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Diagnostyki i Mikrochirurgii Oka LENS</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-424</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Uno-Med</name>
      <address>
        <city>Tarnów</city>
        <zip>33-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>01 -364</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emanuelli Research &amp; Development Center, LLC</name>
      <address>
        <city>Arecibo</city>
        <zip>00613</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Dotal de Investigaciones de Servicios de Salud</name>
      <address>
        <city>Carolina</city>
        <zip>00984</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berrocal and Associates</name>
      <address>
        <city>San Juan</city>
        <zip>00907</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newtown Clinical Research Centre</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pretoria Eye Institute</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0082</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Into Research</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0181</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oftalmológico Fernández-Vega</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Oftalmologia Gil Piña</name>
      <address>
        <city>Huelva</city>
        <zip>21002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Rementeria</name>
      <address>
        <city>Madrid</city>
        <zip>28010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cartujavision</name>
      <address>
        <city>Sevilla</city>
        <zip>41092</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Colombia</country>
  </removed_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>September 24, 2019</results_first_submitted>
  <results_first_submitted_qc>October 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2019</results_first_posted>
  <last_update_submitted>May 21, 2021</last_update_submitted>
  <last_update_submitted_qc>May 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis, Bacterial</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03004924/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 1</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03004924/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 2</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03004924/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 3</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03004924/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 4</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03004924/Prot_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03004924/SAP_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted at 121 centers in 14 countries between 29 Mar 2017 (first participant first visit) and 01 Oct 2018 (last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 1080 participants were screened, of them 753 enrolled and randomized to treatment. One participant was randomized in error and therefore captured only in the intent-to-treat (ITT) population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SHP640</title>
          <description>Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.</description>
        </group>
        <group group_id="P2">
          <title>PVP-I 0.6%</title>
          <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="324"/>
                <participants group_id="P2" count="108"/>
                <participants group_id="P3" count="321"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="297"/>
                <participants group_id="P2" count="94"/>
                <participants group_id="P3" count="293"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by parent/guardian</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed Study Visit</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>HSV1 Positive</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>ITT population included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>SHP640</title>
          <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
        </group>
        <group group_id="B2">
          <title>PVP-I 0.6%</title>
          <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="324"/>
            <count group_id="B2" value="108"/>
            <count group_id="B3" value="321"/>
            <count group_id="B4" value="753"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.2" spread="22.87"/>
                    <measurement group_id="B2" value="43.1" spread="23.03"/>
                    <measurement group_id="B3" value="44.7" spread="23.00"/>
                    <measurement group_id="B4" value="44.3" spread="22.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="199"/>
                    <measurement group_id="B4" value="461"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="122"/>
                    <measurement group_id="B4" value="292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="87"/>
                    <measurement group_id="B4" value="179"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="254"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="230"/>
                    <measurement group_id="B4" value="560"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="250"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="250"/>
                    <measurement group_id="B4" value="588"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5</title>
        <description>Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.</description>
        <time_frame>Day 5</time_frame>
        <population>Modified intent-to-treat (mITT) population included participants who received at least one dose of investigational product (IP) and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Analysis was done in SHP640 and placebo reporting groups only.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5</title>
          <description>Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.</description>
          <population>Modified intent-to-treat (mITT) population included participants who received at least one dose of investigational product (IP) and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Analysis was done in SHP640 and placebo reporting groups only.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="222"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.127</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in response rate</param_type>
            <param_value>7.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>16.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5</title>
        <description>Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.</description>
        <time_frame>Baseline, Day 5</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5</title>
          <description>Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="218"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.500</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in response rate</param_type>
            <param_value>-3.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.8</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Resolution</title>
        <description>Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
        <time_frame>Day 3, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Resolution</title>
          <description>Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Bacterial Eradication</title>
        <description>Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.</description>
        <time_frame>Day 3, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Bacterial Eradication</title>
          <description>Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="214"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bulbar Conjunctival Injection Score</title>
        <description>Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.</description>
        <time_frame>Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Bulbar Conjunctival Injection Score</title>
          <description>Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.84"/>
                    <measurement group_id="O2" value="1.3" spread="0.90"/>
                    <measurement group_id="O3" value="1.1" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.77"/>
                    <measurement group_id="O2" value="0.7" spread="0.88"/>
                    <measurement group_id="O3" value="0.7" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.64"/>
                    <measurement group_id="O2" value="0.4" spread="0.61"/>
                    <measurement group_id="O3" value="0.4" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="196"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.56"/>
                    <measurement group_id="O2" value="0.2" spread="0.47"/>
                    <measurement group_id="O3" value="0.2" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Bulbar Conjunctival Injection Score</title>
        <description>Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.</description>
        <time_frame>Baseline, Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Bulbar Conjunctival Injection Score</title>
          <description>Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.77"/>
                    <measurement group_id="O2" value="-0.8" spread="0.76"/>
                    <measurement group_id="O3" value="-0.9" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="0.87"/>
                    <measurement group_id="O2" value="-1.3" spread="0.99"/>
                    <measurement group_id="O3" value="-1.3" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.91"/>
                    <measurement group_id="O2" value="-1.6" spread="0.86"/>
                    <measurement group_id="O3" value="-1.6" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="196"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.89"/>
                    <measurement group_id="O2" value="-1.8" spread="0.74"/>
                    <measurement group_id="O3" value="-1.8" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ocular Conjunctival Discharge Score</title>
        <description>Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
        <time_frame>Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Ocular Conjunctival Discharge Score</title>
          <description>Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.73"/>
                    <measurement group_id="O2" value="0.8" spread="0.74"/>
                    <measurement group_id="O3" value="0.7" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.57"/>
                    <measurement group_id="O2" value="0.2" spread="0.44"/>
                    <measurement group_id="O3" value="0.4" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.43"/>
                    <measurement group_id="O2" value="0.1" spread="0.31"/>
                    <measurement group_id="O3" value="0.2" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.49"/>
                    <measurement group_id="O2" value="0.0" spread="0.22"/>
                    <measurement group_id="O3" value="0.1" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Ocular Conjunctival Discharge Score</title>
        <description>Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
        <time_frame>Baseline, Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Ocular Conjunctival Discharge Score</title>
          <description>Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.77"/>
                    <measurement group_id="O2" value="-0.8" spread="0.67"/>
                    <measurement group_id="O3" value="-0.9" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="0.74"/>
                    <measurement group_id="O2" value="-1.4" spread="0.75"/>
                    <measurement group_id="O3" value="-1.3" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="0.71"/>
                    <measurement group_id="O2" value="-1.5" spread="0.73"/>
                    <measurement group_id="O3" value="-1.4" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="0.76"/>
                    <measurement group_id="O2" value="-1.6" spread="0.71"/>
                    <measurement group_id="O3" value="-1.6" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Clinical Score</title>
        <description>Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
        <time_frame>Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Clinical Score</title>
          <description>Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.37"/>
                    <measurement group_id="O2" value="2.1" spread="1.39"/>
                    <measurement group_id="O3" value="1.9" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.18"/>
                    <measurement group_id="O2" value="0.9" spread="1.19"/>
                    <measurement group_id="O3" value="1.0" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.93"/>
                    <measurement group_id="O2" value="0.5" spread="0.77"/>
                    <measurement group_id="O3" value="0.6" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.90"/>
                    <measurement group_id="O2" value="0.3" spread="0.55"/>
                    <measurement group_id="O3" value="0.3" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Global Clinical Score</title>
        <description>Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
        <time_frame>Baseline, Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Global Clinical Score</title>
          <description>Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="1.28"/>
                    <measurement group_id="O2" value="-1.6" spread="1.22"/>
                    <measurement group_id="O3" value="-1.8" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.9" spread="1.27"/>
                    <measurement group_id="O2" value="-2.8" spread="1.47"/>
                    <measurement group_id="O3" value="-2.6" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.2" spread="1.36"/>
                    <measurement group_id="O2" value="-3.2" spread="1.25"/>
                    <measurement group_id="O3" value="-3.1" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="1.38"/>
                    <measurement group_id="O2" value="-3.4" spread="1.06"/>
                    <measurement group_id="O3" value="-3.3" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Modified Clinical Resolution</title>
        <description>Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
        <time_frame>Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Modified Clinical Resolution</title>
          <description>Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Expanded Clinical Resolution</title>
        <description>Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
        <time_frame>Day 3, 5, 8 and 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Expanded Clinical Resolution</title>
          <description>Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="226"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Clinical Resolution</title>
        <description>Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.</description>
        <time_frame>Baseline to Day 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Clinical Resolution</title>
          <description>Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="5.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="6" lower_limit="5.0" upper_limit="8.0"/>
                    <measurement group_id="O3" value="8" lower_limit="5.0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Used Rescue Medication</title>
        <description>Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.</description>
        <time_frame>Baseline to Day 12</time_frame>
        <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Used Rescue Medication</title>
          <description>Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.</description>
          <population>mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="223"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.</description>
        <time_frame>From start of study drug administration up to 14 days</time_frame>
        <population>Safety population included all participants who received at least one dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>PVP-I 0.6%</title>
            <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.</description>
          <population>Safety population included all participants who received at least one dose of investigational product.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="323"/>
                <count group_id="O2" value="108"/>
                <count group_id="O3" value="321"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration up to 14 days.</time_frame>
      <desc>One participant was randomized in error and therefore captured in the ITT population, but not in the Safety Population.</desc>
      <group_list>
        <group group_id="E1">
          <title>SHP640</title>
          <description>Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days.</description>
        </group>
        <group group_id="E2">
          <title>PVP-I 0.6%</title>
          <description>Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="323"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="321"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="323"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="67" subjects_at_risk="323"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="108"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation site pain</sub_title>
                <counts group_id="E1" events="68" subjects_affected="67" subjects_at_risk="323"/>
                <counts group_id="E2" events="26" subjects_affected="26" subjects_at_risk="108"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@shire.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03004924
org study id: SHP640-303
secondary id: 2016-003361-25
nct id: NCT03004924
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if an investigational treatment is effective
      compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial
      conjunctivitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5
time frame: Day 5
description: Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
measure: Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5
time frame: Baseline, Day 5
description: Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.
measure: Number of Participants With Clinical Resolution
time frame: Day 3, 8 and 12
description: Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
measure: Number of Participants With Bacterial Eradication
time frame: Day 3, 8 and 12
description: Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.
measure: Bulbar Conjunctival Injection Score
time frame: Day 3, 5, 8 and 12
description: Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
measure: Change From Baseline in the Bulbar Conjunctival Injection Score
time frame: Baseline, Day 3, 5, 8 and 12
description: Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.
measure: Ocular Conjunctival Discharge Score
time frame: Day 3, 5, 8 and 12
description: Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
measure: Change From Baseline in the Ocular Conjunctival Discharge Score
time frame: Baseline, Day 3, 5, 8 and 12
description: Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
measure: Global Clinical Score
time frame: Day 3, 5, 8 and 12
description: Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
measure: Change From Baseline in the Global Clinical Score
time frame: Baseline, Day 3, 5, 8 and 12
description: Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.
measure: Number of Participants With Modified Clinical Resolution
time frame: Day 3, 5, 8 and 12
description: Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
measure: Number of Participants With Expanded Clinical Resolution
time frame: Day 3, 5, 8 and 12
description: Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.
measure: Time to Clinical Resolution
time frame: Baseline to Day 12
description: Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.
measure: Number of Participants Who Used Rescue Medication
time frame: Baseline to Day 12
description: Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to 14 days
description: An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.
arm group label: SHP640
arm group type: Experimental
description: Participants will instill 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days.
arm group label: PVP-I 0.6%
arm group type: Active Comparator
description: Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days.
intervention type: Drug
intervention name: SHP640
description: Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
arm group label: SHP640
intervention type: Drug
intervention name: PVP-I 0.6%
description: Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
arm group label: PVP-I 0.6%
intervention type: Drug
intervention name: Placebo
description: Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Austria
country: Canada
country: Estonia
country: France
country: Hungary
country: Israel
country: Italy
country: Poland
country: Puerto Rico
country: South Africa
country: Spain
country: United States
country: Colombia
responsible party type: Sponsor
mesh term: Conjunctivitis, Bacterial
mesh term: Conjunctivitis
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
provided document: 
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 