NCT01190878

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

A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Inflammation

Interventions

Type	Name	Description
DRUG	ISV-303	0.075% of bromfenac in DuraSite dosed QD
DRUG	ISV-303	0.075% of bromfenac in DuraSite dosed BID
DRUG	DuraSite Vehicle	Vehicle dosed BID
DRUG	Xibrom™	0.09% bromfenac dosed BID

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-08-30
• Last updated: 2021-11-19
• Results posted: 2016-07-13