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 Xibrom™ 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