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

Date de début de l'étude : 1 mai 2013

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