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

Phase 1

Completed

• Conditions: Ocular Inflammation
• Interventions: Drug: ISV-303; Drug: DuraSite Vehicle; Drug: Xibrom™

• Registration Number: NCT01190878
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2012-01-26
• Disposition First Submitted QC: 2012-01-27
• Disposition First Posted: 2012-01-31
• Results First Submitted: 2016-04-26
• Results First Submitted QC: 2016-06-02
• Results First Posted: 2016-07-13
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISV-303 BID	ISV-303	-
DuraSite Vehicle BID	DuraSite Vehicle	-
ISV-303 QD	ISV-303	-
Xibrom BID	Xibrom™	-

Primary Outcome Measures

Name	Time	Method
Ocular Inflammation	15 days	Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.