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

Completed · Phase 2

Conditions studied: Acute Infectious Keratoconjunctivitis

In brief

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.

Key facts

Study ID

NCT05636228

Run by

Invirsa, Inc.

People needed

93

Starts

2023-06-09

Expected to finish

2024-08-22

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Corticosteroid (including but not limited to oral, intranasal, inhaled, topical, etc.) or any immunosuppressant use within 30 days prior to Baseline visit
• On current treatment for herpes keratitis (evidence of herpes keratitis and/or ocular dendrites can be included)
• Known or suspected ocular fungal infection or ocular microsporidia infection

Where it is running

• 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
• King Chulalongkorn Memorial Hospital — Bangkok, Thailand
• Mahidol university — Bangkok, Thailand

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.