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Completed

NCT Number: NCT05636228

Study of INV-102 Ophthalmic Solution in Adults 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King Chulalongkorn Memorial Hospital, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INV-102

Drug

INV-102 Ophthalmic Solution

Vehicle

Drug

Vehicle Ophthalmic Solution

Primary outcomes

  1. To Evaluate the Change in Combined Clinical Score

    Time frame: 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 outcomes

  1. To Evaluate the Percent of participants requiring rescue

    Time frame: Day 3

    To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control

Sponsors and collaborators

Lead sponsor

Invirsa, Inc.

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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