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

NCT05636228 | Completed Phase 2 FDA Drug

• 1 other identifier: INV-102-CS-002
• Study Type: interventional
• Target: 93
• Locations: 2 countries
• Sites: 12

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.

Conditions

Acute Infectious Keratoconjunctivitis

Keywords

pink eye; conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To Evaluate the Percent of participants requiring rescue

  Day 3

Study Arms (2)

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

EXPERIMENTAL

INV-102 ophthalmic solution administered for about 1 week

Drug: INV-102

Vehicle TID

PLACEBO COMPARATOR

INV-102 ophthalmic solution administered for about 1 week

Drug: Vehicle

Interventions

INV-102 DRUG

INV-102 Ophthalmic Solution

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

Vehicle DRUG

Vehicle Ophthalmic Solution

Vehicle TID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Invirsa, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (12)

Global Research Management

Glendale, California, 91204, United States

Location

Foothill Eye Institute

Pasadena, California, 91107, United States

Location

Shettle Eye Research

Largo, Florida, 33773, United States

Location

D & H National Research Centers, INC

Miami, Florida, 33155, United States

Location

My Community Research Center, Inc.

Miami, Florida, 33155, United States

Location

Quantum Clinical Trials

Miami Beach, Florida, 33140, United States

Location

Kannarr Eye Center

Pittsburg, Kansas, 66762, United States

Location

Oculos Clinical Research

Garner, North Carolina, 27529, United States

Location

Athens Eye Care

Athens, Ohio, 45701, United States

Location

Revolution Research/ Lake Travis Eye and Laser Center

Lakeway, Texas, 78738, United States

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Mahidol university

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Conjunctivitis

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: June 9, 2023
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (10); TH (2)