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

Sun Pharmaceutical Industries Limited0 sites169 target enrollmentAugust 2010

ConditionsOcular Inflammation

InterventionsDuraSite Vehicle ISV-303 Xibrom™

DrugsISV-303 DuraSite Vehicle Xibrom™

Overview

Phase: Phase 1
Intervention: DuraSite Vehicle
Conditions: Ocular Inflammation
Sponsor: Sun Pharmaceutical Industries Limited
Enrollment: 169
Primary Endpoint: Ocular Inflammation
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

January 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Pharmaceutical Industries Limited

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

DuraSite Vehicle BID

Intervention: DuraSite Vehicle

ISV-303 BID

Intervention: ISV-303

ISV-303 QD

Intervention: ISV-303

Xibrom BID

Intervention: Xibrom™

Outcomes

Primary Outcomes

Ocular Inflammation

Time Frame: 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.