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

Study Overview
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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.

Official Title
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Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis

Conditions
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Acute Infectious Keratoconjunctivitis

Intervention / Treatment
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* Drug: INV-102
* Drug: Vehicle


Participation Criteria
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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 corneal ulcer Ocular topical steroid use within two weeks prior to baseline visit Ocular topical antibiotic use for less than 24 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INV-102 0.7% Three Times per Day (TID)<br>INV-102 ophthalmic solution administered for about 1 week | Drug: INV-102<br>* INV-102 Ophthalmic Solution<br>|
| Placebo Comparator: Vehicle TID<br>INV-102 ophthalmic solution administered for about 1 week | Drug: Vehicle<br>* Vehicle Ophthalmic Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Change in Combined Clinical Score | To evaluate the efficacy of INV-102 compared to vehicle control in reducing Combined Clinical Score (bulbar hyperemia plus conjunctival discharge) in patients with AIK. Conjunctival hyperemia will be rated by using the modified version of Cornea and Contact Lens Research Unit grading scale for bulbar redness, which ranges from 0 (none) to 4 points (very severe). Conjunctival discharge will be assessed using the chart below from Schwab and Friedlander (2002) to score conjunctival discharge from 0 (absent/normal) to 3 (severe). | Through End of Treatment (Day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Percent of participants requiring rescue | To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pink eye, conjunctivitis