Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis

A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of IVIEW-1201 In The Treatment Of Acute Adenoviral Conjunctivitis

NCT03749317•IVIEW Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

15 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
•2. Ability to voluntarily provide written, signed, and dated to participate in the study.
•3. Subjects of age 15 and over at Visit 1.
•4. Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
•5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
•* Reported presence of signs and/or symptoms of adenoviral conjunctivitis for ≤ 3 days prior to Visit 1
•* Bulbar conjunctival injection: a grade of \>=1 on 0-4 scale of Bulbar Conjunctival Injection Scale
•* Watery conjunctival discharge: a grade of \>=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale
•6. Be willing to discontinue contact lens wear for the duration of the study.
•7. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion Criteria

•1. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
•2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
•3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
•4. Prior enrollment in IVIEW-1201 clinical study.
•5. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
•6. Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study.
•7. Have a preplanned overnight hospitalization during the period of the study.
•8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
•9. Have presence of corneal subepithelial infiltrates at Visit 1
•10. Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebae, other or parasitic).
+18 more criteria

Locations (1)

Disha Eye Hospital

Kolkata, West Bengal, India

Key Dates

Start Date

February 20, 2023

Primary Completion Date

April 30, 2024

Completion Date

December 31, 2024

Last Updated

October 15, 2025

Enrollment

135

ACTUAL participants

Conditions

Adenoviral Conjunctivitis

Interventions

IVIEW-1201

DRUG

Placebo

DRUG

Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

NCT02998541

Adenoviral Conjunctivitis

View study

COMPLETEDNA

Reducing Adenoviral Patient Infected Days

NCT02472223

ConjunctivitisAdenoviral Conjunctivitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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