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

NCT01190878 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2021-11-19

Study results available
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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

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

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-01-31
Completion
2011-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190878 on ClinicalTrials.gov