Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis

Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis

NCT05636228•Invirsa, Inc.

View on ClinicalTrials.gov

Summary

Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patient ≥ 18 years of age
•A clinical diagnosis of AIK with a minimum of a 2+ (moderate) conjunctival hyperemia and a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at least one eye

Exclusion Criteria

•Untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours or more prior to baseline visit
•Infectious blepharitis as the primary cause of ocular hyperemia and discharge in the opinion of the investigator (Note: If the blepharitis is secondary to the conjunctivitis, the patient can be included)
•Suspected allergic conjunctivitis as a primary cause of conjunctival hyperemia (bulbar redness) and/or discharge in the opinion of the Investigator
•Suspected corneal ulcer
•Ocular topical steroid use within two weeks prior to baseline visit
•Ocular topical antibiotic use for less than 24 hours or greater than 96 hours of dosing prior to Baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics)
•Ocular topical povidone iodine use within 1 week prior to baseline visit
•Systemic antibiotic use within 2 weeks prior to baseline visit
•Ocular topical or systemic anti-fungal within 2 weeks prior to baseline visit
•Ocular topical or systemic anti-viral use within 2 weeks prior to baseline visit
+3 more criteria

Locations (12)

Global Research Management

Glendale, California, United States

Foothill Eye Institute

Pasadena, California, United States

Shettle Eye Research

Largo, Florida, United States

D & H National Research Centers, INC

Miami, Florida, United States

My Community Research Center, Inc.

Miami, Florida, United States

Quantum Clinical Trials

Miami Beach, Florida, United States

Kannarr Eye Center

Pittsburg, Kansas, United States

Oculos Clinical Research

Garner, North Carolina, United States

Athens Eye Care

Athens, Ohio, United States

Revolution Research/ Lake Travis Eye and Laser Center

Lakeway, Texas, United States

Key Dates

Start Date

June 9, 2023

Primary Completion Date

August 22, 2024

Completion Date

August 22, 2024

Last Updated

August 22, 2025

Enrollment

ACTUAL participants

Conditions

Acute Infectious Keratoconjunctivitis

Interventions

INV-102

DRUG

Vehicle

DRUG