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Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis

NCT01408082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 917

Last updated 2021-11-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.

Conditions

  • Blepharitis

Interventions

DRUG

ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)

Azithromycin and Dexamethasone twice daily for 2 weeks

DRUG

Azasite

Azasite twice daily for 2 weeks

DRUG

Dexamethasone

Dexamethasone 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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-03-31
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01408082 on ClinicalTrials.gov