NCT01408082

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

A Randomized, Double-Masked, Parallel-Group, Comparative Study 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 917 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2011-08-03
• Last updated: 2021-11-19

Locations

45 sites across 1 country: United States