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

Inclusion Criteria:

• Male or female subjects age 18 or older scheduled for unilateral cataract surgery withposterior chamber intraocular lens implantation
• If a female is of childbearing potential, the subject must agree to and submit anegative pregnancy test before any protocol-specific procedures are conducted. Thesubject must use effective contraception for the duration of the study. Postmenopausal 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 medications for the duration of the study
• Willing and able to follow all instructions and attend all study visits
• Able to self-administer the IMP (or have a caregiver available to instill all doses ofstudy drugs )
• Additional inclusion criteria also apply

Exclusion Criteria:

• Known hypersensitivity or poor tolerance to bromfenac sodium or any component of theIMP or any of the procedural medications
• Currently pregnant, nursing, or planning a pregnancy; or be a woman that has apositive pregnancy test
• Currently suffer from alcohol and/or drug abuse
• Prior (within 30 days of beginning study treatment) or anticipated concurrent use ofan investigational drug or device
• A condition or a situation, which in the investigator's opinion may put the subject atincreased risk, confound study data, or interfere significantly with the subject'sstudy participation
• Additional inclusion criteria also apply