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

NCT06164743 | Completed Phase 2 Results FDA Drug

• 1 other identifier: VVN461-CS-201
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Anterior Chamber Cell: Categorical Cure

  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.

  Day 14

Secondary Outcomes (1)

• Safety of VVN461

  Day 21

Study Arms (3)

VVN461 1.0%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 1.0%

Drug: VVN461 Ophthalmic Solution 1.0%

VVN461 0.5%

EXPERIMENTAL

VVN461 Ophthalmic Solution, 0.5%

Drug: VVN461 Ophthalmic Solution 0.5%

Vehicle

PLACEBO COMPARATOR

VVN461 Vehicle

Drug: Vehicle

Interventions

VVN461 Ophthalmic Solution 1.0% DRUG

Topical ocular drug

VVN461 1.0%

VVN461 Ophthalmic Solution 0.5% DRUG

Topical ocular drug

VVN461 0.5%

Vehicle DRUG

Topical ocular drug

Vehicle

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• VivaVision Biotech, Inc: lead

Study Sites (10)

United Medical Research Institute

Inglewood, California, 90301, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Martel Eye Associates

Rancho Cordova, California, 95670, United States

Location

ICON Eye Care

Grand Junction, Colorado, 81501, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Comprehensive Eye Care, Ltd

Washington, Missouri, 63090, United States

Location

Center For Sight - Las Vegas

Las Vegas, Nevada, 89145, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Keystone Research

Austin, Texas, 78731, United States

Location

Houston Eye Associates

Houston, Texas, 77708, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Joanne Li
• Organization: VivaVisionBio

joanne.li@vivavisionbio.com

(86) 021-58598290

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-masked drug product
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked, parallel, randomized

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: January 11, 2024
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)