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

IVIEW Therapeutics Inc.1 site in 1 country135 target enrollmentFebruary 20, 2023

ConditionsAdenoviral Conjunctivitis

InterventionsIVIEW-1201 Placebo

DrugsIVIEW-1201 Placebo

Overview

Phase: Phase 2
Intervention: IVIEW-1201
Conditions: Adenoviral Conjunctivitis
Sponsor: IVIEW Therapeutics Inc.
Enrollment: 135
Locations: 1
Primary Endpoint: Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 20, 2023

End Date

December 31, 2024

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IVIEW Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•An understanding, ability, and willingness to fully comply with study procedures and restrictions.
•Ability to voluntarily provide written, signed, and dated to participate in the study.
•Subjects of age 15 and over at Visit
•Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
•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
•Be willing to discontinue contact lens wear for the duration of the study.
•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

•Subjects are excluded from the study if any of the following exclusion criteria are met.
•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.
•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.
•Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
•Prior enrollment in IVIEW-1201 clinical study.
•Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
•Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study.
•Have a preplanned overnight hospitalization during the period of the study.
•Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
•Have presence of corneal subepithelial infiltrates at Visit 1