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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
917
Azithromycin and Dexamethasone twice daily for 2 weeks
Azasite twice daily for 2 weeks
Dexamethasone twice daily for 2 weeks
Clinical Resolution
The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Time frame: Day 15
Recurrence of Clinical Signs and Symptoms
The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
Time frame: 6 Month
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Vehicle twice daily for 2 weeks
Arizona Eye Center
Chandler, Arizona, United States
Arizona Center for Clinical Trials LLC
Phoenix, Arizona, United States
Cornea Consultants of Arizona
Phoenix, Arizona, United States
Lugene Eye Institute
Glendale, California, United States
United Medical Research Institute
Inglewood, California, United States
Macy Eye Center
Los Angeles, California, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Associates, Inc.
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
...and 35 more locations