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Completed

NCT Number: NCT06164743

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

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

United Medical Research Institute, Inglewood, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

VVN461 Ophthalmic Solution 1.0%

Drug

Topical ocular drug

VVN461 Ophthalmic Solution 0.5%

Drug

Topical ocular drug

Vehicle

Drug

Topical ocular drug

Primary outcomes

  1. Anterior Chamber Cell: Categorical Cure

    Time frame: Day 14

    Proportion of subjects with grade of 0 using SUN Working Group Grading Scale (0 (none) to 4+ (>50 cells in field). Note - higher values represent a WORSE outcome.

Secondary outcomes

  1. Safety of VVN461

    Time frame: Day 21

    Number of subjects with Adverse Events

Sponsors and collaborators

Lead sponsor

VivaVision Biotech, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2023
Registry last updated
Jun 10, 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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