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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Inflammation

Intervention / Treatment
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* Drug: VVN461 Ophthalmic Solution 1.0%
* Drug: VVN461 Ophthalmic Solution 0.5%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-masked, parallel, randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VVN461 1.0%<br>VVN461 Ophthalmic Solution, 1.0% | Drug: VVN461 Ophthalmic Solution 1.0%<br>* Topical ocular drug<br>|
| Experimental: VVN461 0.5%<br>VVN461 Ophthalmic Solution, 0.5% | Drug: VVN461 Ophthalmic Solution 0.5%<br>* Topical ocular drug<br>|
| Placebo Comparator: Vehicle<br>VVN461 Vehicle | Drug: Vehicle<br>* Topical ocular drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior chamber cell: Categorical cure | Proportion of subjects with grade of 0 | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of VVN461 | Incidence of Adverse Events | Day 21 |