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

Last updated: September 13, 2024
Sponsor: Invirsa, Inc.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

INV-102

Vehicle

Clinical Study ID

NCT05636228
INV-102-CS-002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patient ≥ 18 years of age

  • A clinical diagnosis of AIK with a minimum of a 2+ (moderate) conjunctival hyperemiaand a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at leastone eye

Exclusion

Exclusion Criteria:

  • Untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours ormore prior to baseline visit

  • Infectious blepharitis as the primary cause of ocular hyperemia and discharge in theopinion of the investigator (Note: If the blepharitis is secondary to theconjunctivitis, 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 ofdosing prior to Baseline visit (this does NOT exclude naïve patients or patientsthat 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/orocular dendrites can be included)

  • Known or suspected ocular fungal infection or ocular microsporidia infection

Study Design

Total Participants: 93
Treatment Group(s): 2
Primary Treatment: INV-102
Phase: 2
Study Start date:
June 09, 2023
Estimated Completion Date:
August 22, 2024

Connect with a study center

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330
    Thailand

    Site Not Available

  • Mahidol university

    Bangkok, 10400
    Thailand

    Site Not Available

  • Metta Pracharak Hospital

    Bangkok, 73210
    Thailand

    Site Not Available

  • Rajavithi Hospital

    Bangkok, 10400
    Thailand

    Site Not Available

  • Thammasat University

    Bangkok, 10120
    Thailand

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Foothill Eye Institute

    Pasadena, California 91107
    United States

    Site Not Available

  • Shettle Eye Research

    Largo, Florida 33773
    United States

    Site Not Available

  • D & H National Research Centers, INC

    Miami, Florida 33155
    United States

    Site Not Available

  • My Community Research Center, Inc.

    Miami, Florida 33155
    United States

    Site Not Available

  • Quantum Clinical Trials

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Kannarr Eye Center

    Pittsburg, Kansas 66762
    United States

    Site Not Available

  • Oculos Clinical Research

    Garner, North Carolina 27529
    United States

    Site Not Available

  • Athens Eye Care

    Athens, Ohio 45701
    United States

    Site Not Available

  • Revolution Research/ Lake Travis Eye and Laser Center

    Lakeway, Texas 78738
    United States

    Site Not Available

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