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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03749317

Enrollment

135

Registered

2018-11-21

Start date

2023-02-20

Completion date

2024-12-31

Last updated

2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoviral Conjunctivitis

Keywords

IVIEW-1201, Adenoviral Conjunctivitis

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

Interventions

DRUGIVIEW-1201

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

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

Subjects are excluded from the study if any of the following

Design outcomes

Primary

Measure	Time frame	Description
Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge	Day 6 +/- 1 Day	Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)

Secondary

Measure	Time frame	Description
Viral Eradication	Day 6 +/- 1 Day	Proportion of subjects with negative cell culture-immunofluorescence assay (CC-IFA)

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026