<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/NCT03749317</url>
  </required_header>
  <id_info>
    <org_study_id>IVIEW-1201-01-AIC</org_study_id>
    <nct_id>NCT03749317</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis</brief_title>
  <official_title>A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of IVIEW-1201 In The Treatment Of Acute Adenoviral Conjunctivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVIEW Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IVIEW Therapeutics Inc.</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>
      A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy&#xD;
      and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to&#xD;
      Placebo in the Treatment of Adenoviral Conjunctivitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 19, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</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>Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge</measure>
    <time_frame>Day 6 +/- 1 Day</time_frame>
    <description>Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral Eradication</measure>
    <time_frame>Day 6 +/- 1 Day</time_frame>
    <description>Proportion of subjects with negative cell culture-immunofluorescence assay (CC-IFA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Adenoviral Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IVIEW-1201; four times per day (QID) for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo; four times per day (QID) for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IVIEW-1201</intervention_name>
    <description>IVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Treatment Arm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo drug; QID; one drop per eye, four times per day (QID) for 7 days</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo Treatment Arm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. An understanding, ability, and willingness to fully comply with study procedures and&#xD;
             restrictions.&#xD;
&#xD;
          2. Ability to voluntarily provide written, signed, and dated to participate in the study.&#xD;
&#xD;
          3. Subjects of age 15 and over at Visit 1.&#xD;
&#xD;
          4. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.&#xD;
&#xD;
          5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye&#xD;
             (the same eye as the AdenoPlus positive eye) confirmed by the presence of the&#xD;
             following minimal clinical signs and symptoms in that same eye:&#xD;
&#xD;
               -  Reported presence of signs and/or symptoms of adenoviral conjunctivitis for ≤ 3&#xD;
                  days prior to Visit 1&#xD;
&#xD;
               -  Bulbar conjunctival injection: a grade of &gt;=1 on 0-4 scale of Bulbar Conjunctival&#xD;
                  Injection Scale&#xD;
&#xD;
               -  Watery conjunctival discharge: a grade of &gt;=1 (mild) on a 0-3 Watery Conjunctival&#xD;
                  Discharge Scale&#xD;
&#xD;
          6. Be willing to discontinue contact lens wear for the duration of the study.&#xD;
&#xD;
          7. 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;
        Subjects are excluded from the study if any of the following exclusion criteria are met.&#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 subject unlikely to fully complete the study, or any condition that&#xD;
             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 IVIEW-1201 clinical study.&#xD;
&#xD;
          5. Subjects who are employees, or immediate family members of employees (who are directly&#xD;
             related to study conduct), at the investigational site.&#xD;
&#xD;
          6. Have a history of ocular surgical intervention within ≤ 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 (eg,&#xD;
             uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than&#xD;
             adenoviral conjunctivitis.&#xD;
&#xD;
          9. Have presence of corneal subepithelial infiltrates at Visit 1&#xD;
&#xD;
         10. Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more&#xD;
             consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or&#xD;
             non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebae, other or&#xD;
             parasitic).&#xD;
&#xD;
         11. Age under 15.&#xD;
&#xD;
         12. Prisoner.&#xD;
&#xD;
         13. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).&#xD;
&#xD;
         14. Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity,&#xD;
             congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic&#xD;
             involvement that could affect study variables.&#xD;
&#xD;
         15. 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;
         16. Presence of significant, active condition in the posterior segment which requires&#xD;
             invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor&#xD;
             (VEGF) inhibitors or corticosteroids) and may progress during the study participation&#xD;
             period.&#xD;
&#xD;
         17. Have used any topical ocular or systemic anti-viral or antibiotics within &lt;= 7 days of&#xD;
             enrollment.&#xD;
&#xD;
         18. Have used any topical ocular NSAIDs within &lt;=1 day of enrollment.&#xD;
&#xD;
         19. Have used any topical ophthalmic steroids in the last &lt;=14 days.&#xD;
&#xD;
         20. Have used any systemic corticosteroid agents within &lt;=14 days of Day 1. Stable&#xD;
             (initiated ≥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;
         21. Have used non-corticosteroid immunosuppressive agents within &lt;=14 days of Day 1, oral&#xD;
             or topical or both.&#xD;
&#xD;
         22. 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;
         23. Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled&#xD;
             systemic disease or debilitating disease (eg, cardiovascular disease, hypertension,&#xD;
             sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may&#xD;
             affect the study parameters, per Investigator's discretion.&#xD;
&#xD;
         24. 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;
         25. Within 30 days prior to the first dose of investigational product:&#xD;
&#xD;
               1. Have used an investigational product or device, or&#xD;
&#xD;
               2. Have been enrolled in a clinical study (including vaccine studies) that, in the&#xD;
                  investigator's opinion, may impact this IVIEW-sponsored study.&#xD;
&#xD;
         26. Pregnant women confirmed with dipstick urine pregnancy testing at Screening and at the&#xD;
             final visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francis Mah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scripps Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qi Zhu, MD</last_name>
    <role>Study Director</role>
    <affiliation>IVIEW Therapeutics Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qi Zhu, MD</last_name>
    <phone>617-431-7479</phone>
    <email>qzhu@iviewinc.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Disha Eye Hospital</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700120</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Parag Sarve</last_name>
      <phone>+91-9599466552</phone>
      <email>parag@excellifesciences.com</email>
    </contact>
    <investigator>
      <last_name>Virender Sangwan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVIEW-1201</keyword>
  <keyword>Adenoviral Conjunctivitis</keyword>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03749317
org study id: IVIEW-1201-01-AIC
nct id: NCT03749317
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy
      and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to
      Placebo in the Treatment of Adenoviral Conjunctivitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
time frame: Day 6 +/- 1 Day
description: Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)
measure: Viral Eradication
time frame: Day 6 +/- 1 Day
description: Proportion of subjects with negative cell culture-immunofluorescence assay (CC-IFA)
arm group label: Treatment
arm group type: Experimental
description: IVIEW-1201; four times per day (QID) for 7 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo; four times per day (QID) for 7 days
intervention type: Drug
intervention name: IVIEW-1201
description: IVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days
arm group label: Treatment
other name: Treatment Arm
intervention type: Drug
intervention name: Placebo
description: Placebo drug; QID; one drop per eye, four times per day (QID) for 7 days
arm group label: Placebo
other name: Placebo Treatment Arm
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
healthy volunteers: No
last name: Francis Mah, MD
role: Principal Investigator
affiliation: Scripps Health
last name: Qi Zhu, MD
role: Study Director
affiliation: IVIEW Therapeutics Inc.
last name: Qi Zhu, MD
phone: 617-431-7479
email: qzhu@iviewinc.com
facility: 
status: Recruiting
contact: 
investigator: 
country: India
responsible party type: Sponsor
mesh term: Conjunctivitis, Inclusion
mesh term: Conjunctivitis