<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/NCT02998554</url>
  </required_header>
  <id_info>
    <org_study_id>SHP640-302</org_study_id>
    <secondary_id>2016-002440-16</secondary_id>
    <nct_id>NCT02998554</nct_id>
  </id_info>
  <brief_title>Treatment of Adenoviral Conjunctivitis With SHP640 Compared to 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 Adenoviral 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 in the treatment of adults and children with adenoviral conjunctivitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision, unrelated to safety&#xD;
  </why_stopped>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Actual">May 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2019</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>Percentage of Participants With Clinical Resolution on Day 6</measure>
    <time_frame>Day 6</time_frame>
    <description>Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adenoviral Eradication on Day 6</measure>
    <time_frame>Day 6</time_frame>
    <description>Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 6 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8</measure>
    <time_frame>Day 6 and 8</time_frame>
    <description>Adenovirus viral titer was assessed by quantitative polymerase chain reaction (qPCR) in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 8 and 12/ET</time_frame>
    <description>Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 3, 8 and 12/ET was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 8 and 12/ET</time_frame>
    <description>Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 3, 8 and 12/ET was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
    <description>Individual clinical signs scores for bulbar conjunctival injection and watery conjunctival discharge in the study eye were reported. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represented worse symptoms for both scores. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
    <description>Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Score range from 0 to 7 and higher scores represented worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
    <description>Modified clinical resolution was defined as a global clinical score of 0 or 1 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 6, 8 and 12/ET</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 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
    <description>Cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline was reported. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)</measure>
    <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
    <description>Time to clinical resolution was reported based on the assessments in the study eye.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</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 Day 13</time_frame>
    <description>An adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events that occurred after the first dose of investigational product.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Adenoviral Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>SHP640</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants instructed to 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) (with a minimum of 2 hours between doses) 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 instructed to instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHP640</intervention_name>
    <description>Instill 1 drop of SHP640 (PVP-I 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (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>Placebo</intervention_name>
    <description>Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. 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;
          2. 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;
          3. 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 greater than or equal to (&gt;=) 37 weeks&#xD;
             gestational age at birth).&#xD;
&#xD;
          4. Meet at least 1 of the 2 criteria below: a. Have a positive AdenoPlus® test at Visit 1&#xD;
             in at least 1 eye; b. Have at least 2 of the following 5 criteria, based upon medical&#xD;
             history and examination: i. Symptoms within the past 7 days consistent with acute&#xD;
             upper respiratory tract infection (example: sore throat, cough, rhinorrhea, etc); ii.&#xD;
             Contact within the past 7 days with family members or other individuals with recent&#xD;
             onset of symptoms consistent with conjunctivitis; iii. Acute onset within the past 4&#xD;
             days of 1 or more of the following ocular symptoms: burning/irritation, foreign body&#xD;
             sensation, light sensitivity; iv. Enlarged periauricular lymph node(s); v. Presence of&#xD;
             follicles on tarsal conjunctiva.&#xD;
&#xD;
             Note: If the participant only meets Inclusion Criterion 4a (a positive AdenoPlus test&#xD;
             in at least 1 eye), then the same eye must meet Inclusion Criterion 5.&#xD;
&#xD;
          5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye&#xD;
             confirmed by the presence of the following minimal clinical signs and symptoms in that&#xD;
             same eye: Report presence of signs and/or symptoms of adenoviral conjunctivitis for&#xD;
             less than or equal to (&lt;=) 4 days prior to Visit 1; Bulbar conjunctival injection: a&#xD;
             grade of &gt;=1 on 0-4 scale of Bulbar Conjunctival Injection Scale; Watery conjunctival&#xD;
             discharge: a grade of &gt;=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale.&#xD;
&#xD;
          6. Be willing to discontinue contact lens wear for the duration of the study.&#xD;
&#xD;
          7. 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 American Academy of&#xD;
             Pediatrics (AAP) Policy Statement for Visual System Assessment in Infants, Children,&#xD;
             and Young Adults by Pediatricians. The policy statement recommends formal vision&#xD;
             screening can begin at 3 years of age. VA measurements for children under the age of 3&#xD;
             will be done at the discretion of the investigator. If not done, child should be able&#xD;
             to fixate on and follow a moving object, except participants &lt; 2 months of age who&#xD;
             have not yet developed this ability. Participants &lt; 2 months will be enrolled at the&#xD;
             discretion of the investigator.&#xD;
&#xD;
          8. 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;
          1. 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;
          2. 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;
          3. Have known or suspected intolerance or hypersensitivity to the investigational&#xD;
             product, closely related compounds, or any of the stated ingredients.&#xD;
&#xD;
          4. Prior enrollment in a FST-100 or SHP640 clinical study.&#xD;
&#xD;
          5. Participants who are employees, or immediate family members of employees (who are&#xD;
             directly related to study conduct), at the investigational site.&#xD;
&#xD;
          6. 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;
          7. Have a preplanned overnight hospitalization during the period of the study.&#xD;
&#xD;
          8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation&#xD;
             (example: uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis),&#xD;
             other than adenoviral conjunctivitis.&#xD;
&#xD;
          9. Have presence of corneal subepithelial infiltrates at Visit 1.&#xD;
&#xD;
         10. Have active or history of ocular herpes.&#xD;
&#xD;
         11. 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-adenoviral ocular infection&#xD;
             (example: bacterial, fungal, acanthamoebal, or other parasitic).&#xD;
&#xD;
             Note: History or concomitant presence of presumed seasonal or perennial allergic&#xD;
             conjunctivitis signs/symptoms is not exclusionary.&#xD;
&#xD;
         12. Neonates or infants (that is (ie,) participants &lt; 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;
         13. Neonates or infants (ie, participants &lt; 12 months of age) whose birth mothers had any&#xD;
             sexually transmitted disease within 1 month of delivery or any history of genital&#xD;
             herpes.&#xD;
&#xD;
         14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).&#xD;
&#xD;
         15. Presence of any significant ophthalmic condition (example: retinopathy of prematurity,&#xD;
             congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic&#xD;
             involvement that could affect study variables.&#xD;
&#xD;
         16. 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;
         17. Have any known clinically significant optic nerve defects.&#xD;
&#xD;
         18. 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;
         19. Presence of significant, active condition in the posterior segment which requires&#xD;
             invasive treatment (example: intravitreal treatment with VEGF inhibitors or&#xD;
             corticosteroids) and may progress during the study participation period.&#xD;
&#xD;
         20. Have used any topical ocular or systemic anti-virals or antibiotics within &lt;= 7 days&#xD;
             of enrollment.&#xD;
&#xD;
         21. Have used any topical ocular NSAIDs within &lt;= 1 day of enrollment.&#xD;
&#xD;
         22. Have used any topical ophthalmic steroids in the last &lt;= 14 days.&#xD;
&#xD;
         23. 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 peri-ocular area.&#xD;
&#xD;
         24. Have used non-corticosteroid immunosuppressive agents within &lt;= 14 days of Day 1.&#xD;
&#xD;
         25. 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;
         26. Have any significant ocular disease (example: Sjogren's syndrome) or any uncontrolled&#xD;
             systemic disease or debilitating disease (example: cardiovascular disease,&#xD;
             hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis),&#xD;
             that may affect the study parameters, per investigator's discretion.&#xD;
&#xD;
         27. 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 (antihepatitis A virus immunoglobulin M), or organ or bone&#xD;
             marrow transplantation.&#xD;
&#xD;
         28. Within 30 days prior to the first dose of investigational product: Have used an&#xD;
             investigational product or device, or Have been enrolled in a clinical study&#xD;
             (including vaccine studies) that, in the investigator's opinion, may impact this&#xD;
             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>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>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>Wolstan and Goldberg Eye Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</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>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>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>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>International Research Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</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>Sabates Eye Centers</name>
      <address>
        <city>Leawood</city>
        <state>Kansas</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians to Children &amp; Adolescents</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</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>Shire Call Center</name>
      <address>
        <city>Lexington</city>
        <state>Massachusetts</state>
        <zip>02421</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>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>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>Fichte, Endl and 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>Apex Eye Kenwood</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</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>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>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>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>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>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>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>Emanuelli Research &amp; Development Center, LLC</name>
      <address>
        <city>Arecibo</city>
        <zip>00613</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Puerto Rico, School of Medicine</name>
      <address>
        <city>Carolina</city>
        <zip>00984</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>May 13, 2020</results_first_submitted>
  <results_first_submitted_qc>May 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 29, 2020</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, Inclusion</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>June 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02998554/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/54/NCT02998554/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/54/NCT02998554/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/54/NCT02998554/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>May 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02998554/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>June 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02998554/SAP_005.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 30 centers in the United States and Puerto Rico between 28 March 2017 (first participant first visit) and 16 May 2019 (last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 156 participants were randomized and received the treatment. Out of them, 134 participants completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SHP640</title>
          <description>Participants administered one 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>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants administered one 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="79"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population consisted of all screened participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>SHP640</title>
          <description>Participants administered one 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>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
        </group>
        <group group_id="B3">
          <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="79"/>
            <count group_id="B2" value="77"/>
            <count group_id="B3" value="156"/>
          </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="42.4" spread="21.57"/>
                    <measurement group_id="B2" value="41.3" spread="21.21"/>
                    <measurement group_id="B3" value="41.9" spread="21.33"/>
                  </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="47"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Clinical Resolution on Day 6</title>
        <description>Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.</description>
        <time_frame>Day 6</time_frame>
        <population>Modified Intent to Treat (mITT) population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Resolution on Day 6</title>
          <description>Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.</description>
          <population>Modified Intent to Treat (mITT) population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                    <measurement group_id="O2" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adenoviral Eradication on Day 6</title>
        <description>Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 6 was reported.</description>
        <time_frame>Day 6</time_frame>
        <population>mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adenoviral Eradication on Day 6</title>
          <description>Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 6 was reported.</description>
          <population>mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8</title>
        <description>Adenovirus viral titer was assessed by quantitative polymerase chain reaction (qPCR) in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
        <time_frame>Day 6 and 8</time_frame>
        <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8</title>
          <description>Adenovirus viral titer was assessed by quantitative polymerase chain reaction (qPCR) in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
          <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)</title>
        <description>Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 3, 8 and 12/ET was reported.</description>
        <time_frame>Day 3, 8 and 12/ET</time_frame>
        <population>mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)</title>
          <description>Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 3, 8 and 12/ET was reported.</description>
          <population>mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="12"/>
              </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="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                    <measurement group_id="O2" value="16.7"/>
                  </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="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12/ET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)</title>
        <description>Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 3, 8 and 12/ET was reported.</description>
        <time_frame>Day 3, 8 and 12/ET</time_frame>
        <population>mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific time point.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)</title>
          <description>Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 3, 8 and 12/ET was reported.</description>
          <population>mITT population consisted of a subset of the ITT Population who received at least one dose of investigational product and has a positive CC-IFA adenovirus test at baseline in the study eye. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="12"/>
              </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="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                    <measurement group_id="O2" value="0"/>
                  </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="7"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3"/>
                    <measurement group_id="O2" value="44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12/ET</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)</title>
        <description>Individual clinical signs scores for bulbar conjunctival injection and watery conjunctival discharge in the study eye were reported. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represented worse symptoms for both scores. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
        <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
        <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants received 1 drop of SHP640 (Povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received 1 drop of placebo matched to SHP640 ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)</title>
          <description>Individual clinical signs scores for bulbar conjunctival injection and watery conjunctival discharge in the study eye were reported. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represented worse symptoms for both scores. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
          <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)</title>
        <description>Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Score range from 0 to 7 and higher scores represented worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
        <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
        <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)</title>
          <description>Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Score range from 0 to 7 and higher scores represented worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
          <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)</title>
        <description>Modified clinical resolution was defined as a global clinical score of 0 or 1 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
        <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
        <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)</title>
          <description>Modified clinical resolution was defined as a global clinical score of 0 or 1 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
          <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)</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 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
        <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
        <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)</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 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
          <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)</title>
        <description>Cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline was reported. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.</description>
        <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
        <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)</title>
          <description>Cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline was reported. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.</description>
          <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)</title>
        <description>Time to clinical resolution was reported based on the assessments in the study eye.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
        <time_frame>Day 3, 6, 8 and 12/ET</time_frame>
        <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one drop of placebo ophthalmic solution in each eye QID for 7 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)</title>
          <description>Time to clinical resolution was reported based on the assessments in the study eye.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.</description>
          <population>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety. Hence, for this outcome measure, the planned data collection and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_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 unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events that occurred after the first dose of investigational product.</description>
        <time_frame>From start of study drug administration up to Day 13</time_frame>
        <population>Safety Population consisted of all screened participants who received at least one dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>SHP640</title>
            <description>Participants administered one 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>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants administered one 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 unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events that occurred after the first dose of investigational product.</description>
          <population>Safety Population consisted of all screened 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="79"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration up to Day 13</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SHP640</title>
          <description>Participants administered one 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>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants administered one 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="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</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="20" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Corneal infiltrates</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation site pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="77"/>
              </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>
    <limitations_and_caveats>The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety.</limitations_and_caveats>
    <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/NCT02998554
org study id: SHP640-302
secondary id: 2016-002440-16
nct id: NCT02998554
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 in the treatment of adults and children with adenoviral conjunctivitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Clinical Resolution on Day 6
time frame: Day 6
description: Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participants bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 6 was reported.
measure: Percentage of Participants With Adenoviral Eradication on Day 6
time frame: Day 6
description: Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 6 was reported.
measure: Absolute Change and Change From Baseline in Adenovirus Viral Titer on Day 6 and 8
time frame: Day 6 and 8
description: Adenovirus viral titer was assessed by quantitative polymerase chain reaction (qPCR) in the study eye. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
measure: Percentage of Participants With Adenoviral Eradication on Day 3, 8 and 12/Early Termination (ET)
time frame: Day 3, 8 and 12/ET
description: Adenoviral eradication for the study eye was defined as negative CC-IFA in that eye. CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline. Percentage of participants with adenoviral eradication on Day 3, 8 and 12/ET was reported.
measure: Percentage of Participants With Clinical Resolution on Day 3, 8 and 12/Early Termination (ET)
time frame: Day 3, 8 and 12/ET
description: Clinical resolution of adenoviral conjunctivitis was defined as the absence (score = 0) of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her cell culture-immunofluorescence assay (CC-IFA) results at baseline. Higher scores represented worse symptoms for both scales. Percentage of participants with clinical resolution on Day 3, 8 and 12/ET was reported.
measure: Number of Participants With Individual Clinical Signs Score at Day 3, 6, 8 and 12/Early Termination (ET)
time frame: Day 3, 6, 8 and 12/ET
description: Individual clinical signs scores for bulbar conjunctival injection and watery conjunctival discharge in the study eye were reported. Bulbar conjunctival injection was assessed based on a 0 (Normal conjunctival vascular pattern)-4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from the validated bulbar redness (VBR) scale. Watery conjunctival discharge was assessed based on a 0-3 scale (0 - None and 3 - Severe: Abundant quantity of watery discharge observed in the lower conjunctival fornix and in the lower lid margin). Higher score represented worse symptoms for both scores. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
measure: Number of Participants With Global Clinical Score at Day 3, 6, 8 and 12/Early Termination (ET)
time frame: Day 3, 6, 8 and 12/ET
description: Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge in the study eye. Score range from 0 to 7 and higher scores represented worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
measure: Percentage of Participants With Modified Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)
time frame: Day 3, 6, 8 and 12/ET
description: Modified clinical resolution was defined as a global clinical score of 0 or 1 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
measure: Percentage of Participants With Expanded Clinical Resolution at Day 3, 6, 8 and 12/Early Termination (ET)
time frame: Day 3, 6, 8 and 12/ET
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 in the study eye. Global clinical score was the sum of bulbar conjunctival injection and watery conjunctival discharge. Score range from 0 to 7 and higher scores represent worse symptoms. The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
measure: Percentage of Participants With Cross-Over Infection at Day 3, 6, 8 and 12/Early Termination (ET)
time frame: Day 3, 6, 8 and 12/ET
description: Cross-over infection to a participant's fellow eye for participants with only 1 infected eye at baseline was reported. The CC-IFA for each eye was conducted using conjunctival swab samples collected at each visit to determine the presence of adenovirus.
measure: Time to Clinical Resolution on Day 3, 6, 8 and 12/Early Termination (ET)
time frame: Day 3, 6, 8 and 12/ET
description: Time to clinical resolution was reported based on the assessments in the study eye.The study eye was defined based on participant's bulbar conjunctival redness and watery conjunctival discharge scores, as well as his/her CC-IFA results at baseline.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: From start of study drug administration up to Day 13
description: An adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Treatment-Emergent Adverse Events (TEAEs) were defined as those adverse events that occurred after the first dose of investigational product.
arm group label: SHP640
arm group type: Experimental
description: Participants instructed to 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) (with a minimum of 2 hours between doses) for 7 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants instructed to instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
intervention type: Drug
intervention name: SHP640
description: Instill 1 drop of SHP640 (PVP-I 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.
arm group label: SHP640
intervention type: Drug
intervention name: Placebo
description: Instill 1 drop of placebo ophthalmic solution in each eye QID 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
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Conjunctivitis, Inclusion
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/
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reported events: 
certain agreements: 
limitations and caveats: The study was terminated as the sponsor discontinued the SHP640 clinical development with reason unrelated to safety.
point of contact: 