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

Phase 2

Completed

• Conditions: Inflammation
• Interventions: Drug: VVN461 Ophthalmic Solution 1.0%; Drug: VVN461 Ophthalmic Solution 0.5%; Drug: Vehicle

• Registration Number: NCT06164743
• Lead Sponsor: VivaVision Biotech, Inc

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

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 Timeline

• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Study Start: 2024-01-11
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VVN461 1.0%	VVN461 Ophthalmic Solution 1.0%	VVN461 Ophthalmic Solution, 1.0%
VVN461 0.5%	VVN461 Ophthalmic Solution 0.5%	VVN461 Ophthalmic Solution, 0.5%
Vehicle	Vehicle	VVN461 Vehicle

Primary Outcome Measures

Name	Time	Method
Anterior chamber cell: Categorical cure	Day 14	Proportion of subjects with grade of 0

Secondary Outcome Measures

Name	Time	Method
Safety of VVN461	Day 21	Incidence of Adverse Events

Trial Locations

Locations (10)

Keystone Research; 🇺🇸 Austin, Texas, United States

United Medical Research Institute; 🇺🇸 Inglewood, California, United States

Comprehensive Eye Care, Ltd; 🇺🇸 Washington, Missouri, United States

Cincinnati Eye Institute; 🇺🇸 Cincinnati, Ohio, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States

Martel Eye Associates; 🇺🇸 Rancho Cordova, California, United States

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Levenson Eye Associates; 🇺🇸 Jacksonville, Florida, United States

ICON Eye Care; 🇺🇸 Grand Junction, Colorado, United States

Center For Sight - Las Vegas; 🇺🇸 Las Vegas, Nevada, United States