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

January 31, 2024 updated by: VivaVision Biotech, Inc

A Phase 2, Double-masked, Randomized, Vehicle-controlled Study of VVN461 Ophthalmic Solution in Treating Post -Operative Ocular Inflammation in Subjects Undergoing Routine Unilateral Cataract Surgery

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Inglewood, California, United States, 90301
        • Recruiting
        • United Medical Research Institute
        • Contact:
        • Principal Investigator:
          • James Peace, MD
      • Petaluma, California, United States, 94954
        • Recruiting
        • North Bay Eye Associates
        • Contact:
        • Principal Investigator:
          • Jason Bacharach, M.D.
      • Rancho Cordova, California, United States, 95670
        • Recruiting
        • Martel Eye Associates
        • Contact:
        • Principal Investigator:
          • Joseph Martel, M.D.
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • ICON Eye Care
        • Contact:
        • Principal Investigator:
          • James A Fox, M.D.
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Levenson Eye Associates
        • Principal Investigator:
          • Jeffrey Levenson, MD
        • Contact:
    • Missouri
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Comprehensive Eye Care, Ltd
        • Contact:
          • Michelle Mueller
          • Phone Number: 636-390-3999
        • Principal Investigator:
          • Michael S Korenfeld, M.D.
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Recruiting
        • Center For Sight - Las Vegas
        • Principal Investigator:
          • Eva Liang, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Cincinnati Eye Institute
        • Contact:
        • Principal Investigator:
          • Michael L Nordlund, M.D., Ph.D.
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Keystone Research
        • Contact:
        • Principal Investigator:
          • Thomas R Walters, M.D.
      • Houston, Texas, United States, 77708
        • Recruiting
        • Houston Eye Associates
        • Contact:
        • Principal Investigator:
          • Kevin Y Jong, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 privacy authorization(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 phacoemulsification extraction and implantation of an intraocular lens.

Exclusion Criteria:

  • Any ocular pain at Visit 1 (Screening)
  • Recent use of corticosteroids or oral non-steroidal anti-inflammatory drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VVN461 1.0%
VVN461 Ophthalmic Solution, 1.0%
Drug: VVN461 Ophthalmic Solution 1.0%
Topical ocular drug
Experimental: VVN461 0.5%
VVN461 Ophthalmic Solution, 0.5%
Drug: VVN461 Ophthalmic Solution 0.5%
Topical ocular drug
Placebo Comparator: Vehicle
VVN461 Vehicle
Drug: Vehicle
Topical ocular drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior chamber cell: Categorical cure
Time Frame: Day 14
Proportion of subjects with grade of 0
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of VVN461
Time Frame: Day 21
Incidence of Adverse Events
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VivaVision Biotech, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVN461-CS-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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