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Completed
NCT05636228
Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis
Conditions: Acute Infectious Keratoconjunctivitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 93
Sponsor: Invirsa, Inc.
Location: Global Research Management Glendale California
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 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 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
Source: ClinicalTrials.gov (NCT05636228). StuddyBuddy aggregates publicly available trial information.