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

NCT01190878 ↗

Phase 1/2 Completed 169 enrolled Sun Pharmaceutical Industries, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-08
Primary completion: 2011-01
Completion: 2011-01

Publications

Trattler W, Hosseini K. Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study. Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bromfenac	Other / unclassified	0.075 %	Topical
Subject	Bromfenac	Other / unclassified	0.09 %	Topical

Indications

No indication recorded.