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

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

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

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