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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Infectious Keratoconjunctivitis
• Intervention / Treatment: Drug: INV-102; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Invirsa Call Center; Phone Number: +1 614-334-1765; Email: info@invirsa.com
• Study Contact Backup: Name: Robert Shalwitz, MD; Phone Number: +1 614-334-1765; Email: rshalwitz@invirsa.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10120
    • Withdrawn
    • Thammasat University
  • Bangkok, Thailand, 10330
    • Terminated
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Terminated
    • Mahidol university
  • Bangkok, Thailand, 10400
    • Withdrawn
    • Rajavithi Hospital
  • Bangkok, Thailand, 73210
    • Withdrawn
    • Metta Pracharak Hospital
• United States
  • California
    • Glendale, California, United States, 91204
      • Recruiting
      • Global Research Management
      • Contact: Sheriff El-Harazi, MD
    • Pasadena, California, United States, 91107
      • Recruiting
      • Foothill Eye Institute
      • Contact: Raymond Shelton, MD
  • Florida
    • Largo, Florida, United States, 33773
      • Recruiting
      • Shettle Eye Research
      • Contact: P. Lee Shettle, DO
    • Miami, Florida, United States, 33155
      • Recruiting
      • D & H National Research Centers, INC
      • Contact: Jorge Amaya, MD
    • Miami, Florida, United States, 33155
      • Recruiting
      • My Community Research Center, Inc.
      • Contact: Richard Perez, MD
    • Miami Beach, Florida, United States, 33140
      • Recruiting
      • Quantum Clinical Trials
      • Contact: Shani Reich, MD
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Recruiting
      • Kannarr Eye Center
      • Contact: Shane Kannar, OD
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • Recruiting
      • Oculos Clinical Research
      • Contact: Carole Aune, OD
  • Ohio
    • Athens, Ohio, United States, 45701
      • Recruiting
      • Athens Eye Care
      • Contact: Shane Foster, OD
  • Texas
    • Lakeway, Texas, United States, 78738
      • Recruiting
      • Revolution Research/ Lake Travis Eye and Laser Center
      • Contact: Kyle Rhodes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Invirsa, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Estimated): May 15, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pink eye; conjunctivitis
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Infections, Bacterial; Eye Infections; Infections; Communicable Diseases; Keratoconjunctivitis, Infectious; Keratoconjunctivitis
• Other Study ID Numbers: INV-102-CS-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No