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

VivaVision Biotech, Inc91 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Inflammation

Interventions

VVN461 Ophthalmic Solution 1.0%DRUG

Topical ocular drug

VVN461 Ophthalmic Solution 0.5%DRUG

Topical ocular drug

VehicleDRUG

Topical ocular drug

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (10)

United Medical Research Institute

Inglewood, California, United States

North Bay Eye Associates

Petaluma, California, United States

Martel Eye Associates

Rancho Cordova, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 14

Secondary Outcomes

Safety of VVN461

Number of subjects with Adverse Events

Time frame: Day 21

Data from ClinicalTrials.gov

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