Overview

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

Status:
Completed
Trial end date:
2013-01-01
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 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