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

Invirsa

Status and phase: Enrolling; Phase 2

Conditions: Acute Infectious Keratoconjunctivitis

Treatments: Drug: INV-102; Drug: Vehicle

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT05636228

INV-102-CS-002

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

INV-102 0.7% Three Times per Day (TID)

Experimental group

Description:

INV-102 ophthalmic solution administered for about 1 week

Treatment:

Drug: INV-102

Vehicle TID

Placebo Comparator group

Description:

INV-102 ophthalmic solution administered for about 1 week

Treatment:

Drug: Vehicle