Overview

Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibromâ„¢ when dosed for 2 weeks in post-cataract-surgery volunteers.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
InSite Vision
Sun Pharma Global FZE
Treatments:
Bromfenac
Criteria
Inclusion Criteria:

- Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular
extraction) with posterior chamber intraocular lens implantation on the day prior to
study enrollment

- Meet the best corrected visual acuity score requirement

- Meet the IOP requirement

- 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

- Use of any ocular topical, or systemic medication that could interfere with normal
lacrimation, wound healing, the test agent, or the interpretation of study results,
within 1 week prior to Day of Surgery

- Additional exclusion criteria also apply