Comparison Study of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.

Official Title
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A Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 to DuraSite Vehicle in Cataract Surgery Subjects

Conditions
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Ocular Inflammation

Intervention / Treatment
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* Drug: ISV-303
* Other: DuraSite Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months Signature of the subject on the Informed Consent Form Willing to avoid disallowed medication for the duration of the study. Willing and able to follow all instructions and attend all study visits Able to self-administer study drug (or have a caregiver available to instill all doses of study drug) Additional inclusion criteria also apply Exclusion Criteria: Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test Currently suffer from alcohol and/or drug abuse Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation Additional exclusion criteria also apply

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISV-303<br>0.075% bromfenac in DuraSite vehicle dosed BID | Drug: ISV-303<br>* Bromfenac in DuraSite<br>|
| Placebo Comparator: DuraSite Vehicle<br>DuraSite Vehicle dosed BID | Other: DuraSite Vehicle<br>* DuraSite Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Inflammation | Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications. | 15 days |