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Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects

NCT01543490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2021-11-19

Study results available
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Summary

The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active, symptomatic Blepharitis.

Conditions

  • Active, Symptomatic Blepharitis

Interventions

DRUG

ISV-305

Dexamethasone in DuraSite® 2 twice daily for 2 weeks

OTHER

Vehicle

Vehicle twice daily for 2 weeks

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2020-02-04
Completion
2020-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01543490 on ClinicalTrials.gov