NCT06164743

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: VivaVision Biotech, Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Inflammation

Interventions

Type	Name	Description
DRUG	VVN461 Ophthalmic Solution 1.0%	Topical ocular drug
DRUG	VVN461 Ophthalmic Solution 0.5%	Topical ocular drug
DRUG	Vehicle	Topical ocular drug

Timeline

• Start date: 2024-01-11
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2023-12-11
• Last updated: 2025-06-10
• Results posted: 2025-06-10

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study