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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InSite Vision; Sun Pharma Global FZE
• Treatments: Bromfenac

Criteria

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 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 of study drugs )

• Additional inclusion criteria also apply

Exclusion Criteria:

• Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP 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 inclusion criteria also apply