Phase 2: VVN461 Ophthalmic Solution for Post -Operative Ocular Inflammation After Cataract Surgery

Last updated: June 9, 2025
Sponsor: VivaVision Biotech, Inc
Overall Status: Completed

Phase

2

Condition

Vision Loss

Eye Disease

Inflammation

Treatment

VVN461 Ophthalmic Solution 0.5%

VVN461 Ophthalmic Solution 1.0%

Vehicle

Clinical Study ID

NCT06164743
VVN461-CS-201
  • Ages > 21
  • All Genders

Study Summary

This is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the United States (US) in subjects undergoing routine unilateral cataract extraction and lens replacement (CELR) surgery via phacoemulsification

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥21 years of age and in good general health at Visit 1 (Screening)

  • Willing and able to provide informed consent and provide relevant privacyauthorization(s)

  • Willing and able to comply with study requirements and visit schedule

  • Clear ocular media (other than cataract) in the study eye

  • Planning to undergo routine unilateral cataract surgery via phacoemulsificationextraction and implantation of an intraocular lens.

Exclusion

Exclusion Criteria:

  • Any ocular pain at Visit 1 (Screening)

  • Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs

Study Design

Total Participants: 91
Treatment Group(s): 3
Primary Treatment: VVN461 Ophthalmic Solution 0.5%
Phase: 2
Study Start date:
January 11, 2024
Estimated Completion Date:
May 15, 2024

Study Description

This is a phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the US assessing the safety and ocular efficacy of VVN461 for treating post-operative ocular inflammation in subjects who undergo routine unilateral CELR surgery via phacoemulsification without surgical complication. Approximately 90 subjects (30 per group) will be randomized in a 1:1:1 ratio. Subjects will administer 1 eye drop in the study eye four times a day (QID) for 14 days.

Connect with a study center

  • United Medical Research Institute

    Inglewood, California 90301
    United States

    Site Not Available

  • North Bay Eye Associates

    Petaluma, California 94954
    United States

    Site Not Available

  • Martel Eye Associates

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • ICON Eye Care

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Levenson Eye Associates

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Comprehensive Eye Care, Ltd

    Washington, Missouri 63090
    United States

    Site Not Available

  • Center For Sight - Las Vegas

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77708
    United States

    Site Not Available

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