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

Phase 2

Recruiting

• Conditions: Acute Infectious Keratoconjunctivitis
• Interventions: Drug: INV-102; Drug: Vehicle

• Registration Number: NCT05636228
• Lead Sponsor: Invirsa, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-05
• Study Start: 2023-06-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INV-102 0.7% Three Times per Day (TID)	INV-102	INV-102 ophthalmic solution administered for about 1 week
Vehicle TID	Vehicle	INV-102 ophthalmic solution administered for about 1 week

Primary Outcome Measures

Name	Time	Method
To Evaluate the Change in Combined Clinical Score	Through End of Treatment (Day 8)	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).

Secondary Outcome Measures

Name	Time	Method
To Evaluate the Percent of participants requiring rescue	Day 3	To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control

Trial Locations

Locations (12)

Global Research Management; 🇺🇸 Glendale, California, United States

Foothill Eye Institute; 🇺🇸 Pasadena, California, United States

Shettle Eye Research; 🇺🇸 Largo, Florida, United States

Quantum Clinical Trials; 🇺🇸 Miami Beach, Florida, United States

D & H National Research Centers, INC; 🇺🇸 Miami, Florida, United States

My Community Research Center, Inc.; 🇺🇸 Miami, Florida, United States

Kannarr Eye Center; 🇺🇸 Pittsburg, Kansas, United States

Oculos Clinical Research; 🇺🇸 Garner, North Carolina, United States

Athens Eye Care; 🇺🇸 Athens, Ohio, United States

Revolution Research/ Lake Travis Eye and Laser Center; 🇺🇸 Lakeway, Texas, United States

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Mahidol university; 🇹🇭 Bangkok, Thailand