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

NCT03749317 | Completed Phase 2 FDA Drug

• 1 other identifier: IVIEW-1201-01-AIC
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Conditions

Adenoviral Conjunctivitis

Keywords

IVIEW-1201; Adenoviral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge

  Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)

  Day 6 +/- 1 Day

Secondary Outcomes (1)

• Viral Eradication

  Day 6 +/- 1 Day

Study Arms (2)

Treatment

EXPERIMENTAL

IVIEW-1201; four times per day (QID) for 7 days

Drug: IVIEW-1201

Placebo

PLACEBO COMPARATOR

Placebo; four times per day (QID) for 7 days

Drug: Placebo

Interventions

IVIEW-1201 DRUG

IVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days

Also known as: Treatment Arm

Treatment

Placebo DRUG

Placebo drug; QID; one drop per eye, four times per day (QID) for 7 days

Also known as: Placebo Treatment Arm

Placebo

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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.

You may not qualify if:

• 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
• 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).
• Age under 15.
• Prisoner.
• Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
• Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
• Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.

Sponsors & Collaborators

• IVIEW Therapeutics Inc.: lead

Study Sites (1)

Disha Eye Hospital

Kolkata, West Bengal, 700120, India

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 21, 2018
• Study Start: February 20, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

IN (1)