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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Invirsa, Inc.
• Collaborator: Biomedical Advanced Research and Development Authority

Criteria

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 corneal ulcer

• Ocular topical steroid use within two weeks prior to baseline visit

• Ocular topical antibiotic use for less than 36 hours of dosing prior to baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics)

• Ocular topical antibiotic use greater than 96 hours prior to baseline visit

• Ocular topical povidone iodine use within one week prior to baseline visit

• Systemic antibiotic use within two weeks prior to baseline visit

• Ocular topical or systemic anti-fungal within two weeks prior to baseline visit

• Ocular topical or systemic anti-viral use within two weeks prior to baseline visit

• Systemic steroid or any immunosuppressant 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

• Suspected ocular microsporidia infection