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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2024-08-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Infectious Keratoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

INV-102 ophthalmic solution administered for about 1 week

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

INV-102 Ophthalmic Solution

Vehicle TID

INV-102 ophthalmic solution administered for about 1 week

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle Ophthalmic Solution

Interventions

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INV-102

INV-102 Ophthalmic Solution

Intervention Type DRUG

Vehicle

Vehicle Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No