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Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

NCT01808547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

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 of topical administration of ISV-303 compared with Durasite Vehicle.

Conditions

  • Ocular Inflammation

Interventions

DRUG

ISV-303

0.075% bromfenac in DuraSite dosed BID

OTHER

DuraSite Vehicle

DuraSite vehicle 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
2013-05-31
Primary Completion
2013-11-30
Completion
2013-11-30

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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 NCT01808547 on ClinicalTrials.gov