Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
- Conditions
- Blepharitis
- Interventions
- Registration Number
- NCT01408082
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 917
- Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
- Signature of the subject or legally authorized representative on the Informed Consent Form.
- Are willing and able to follow all instructions and attend all study visits.
- Are willing to avoid disallowed medication for the duration of the study.
- If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
- Additional inclusion criteria also apply.
- Have known sensitivity or poor tolerance to any component of the Investigational Drug.
- Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
- Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
- Have used any non-diagnostic topical ophthalmic solutions in the study eye.
- Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
- Currently suffer from alcohol and/or drug abuse.
- Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device.
- Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
- Additional exclusion criteria also apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle - AzaSite Azasite - ISV-502 ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) - Dexamethasone Dexamethasone -
- Primary Outcome Measures
Name Time Method Clinical Resolution Day 15 The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Recurrence of Clinical Signs and Symptoms 6 Month The primary efficacy endpoint for the comparison of ISV-502 and Dexamethasone is recurrence of clinical signs and symptoms by 6-Month Follow-up.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Macy Eye Center
🇺🇸Los Angeles, California, United States
Center for Sight, Inc.
🇺🇸Fall River, Massachusetts, United States
West Coast Eye Care Associates
🇺🇸San Diego, California, United States
Nevada Eye Care Professionals
🇺🇸Las Vegas, Nevada, United States
San Diego Eye and Laser Center
🇺🇸San Diego, California, United States
Arizona Eye Center
🇺🇸Chandler, 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
North Valley Eye Medical Group, Inc.
🇺🇸Mission Hills, California, United States
North Bay Associates, Inc.
🇺🇸Petaluma, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Shasta Eye Medical Group, Inc.
🇺🇸Redding, California, United States
Florida Eye Microsurgicial Institute, Inc.
🇺🇸Boynton Beach, Florida, United States
ZASA Clinical Research, LLC
🇺🇸Boynton Beach, Florida, United States
Vision Eye Care Center
🇺🇸Palm Springs, Florida, United States
Lakeview Optical
🇺🇸Gretna, Louisiana, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Comprehensive Eye Care Ltd
🇺🇸Washington, Missouri, United States
Abrams Eye Institute
🇺🇸Las Vegas, Nevada, United States
Eye Care Associates of Nevada
🇺🇸Sparks, Nevada, United States
Ophthalmic Consultants of Long Island
🇺🇸Valley Stream, New York, United States
David Ringel, OD PA
🇺🇸Sewell, New Jersey, United States
South Shore Eye Care
🇺🇸Wantagh, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
🇺🇸Charlotte, North Carolina, United States
James Branch, MD
🇺🇸Winston-Salem, North Carolina, United States
Mundorf Eye Center
🇺🇸Charlotte, North Carolina, United States
Eye Care Associates of Greater Cincinnati, Inc.
🇺🇸Madeira, Ohio, United States
Roseburg Research Associates, LLC
🇺🇸Roseburg, Oregon, United States
Research Across America @ Wyomissing Optometric Center Inc
🇺🇸Wyomissing, Pennsylvania, United States
Philadelphia Eye Associates
🇺🇸Philadelphia, Pennsylvania, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Arizona Center for Clinical Trials LLC
🇺🇸Phoenix, Arizona, United States
Magruder Eye Institute
🇺🇸Orlando, Florida, United States
International Research Center
🇺🇸Tampa, Florida, United States
Richard Eiferman, MD
🇺🇸Louisville, Kentucky, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
David Shulman, MD
🇺🇸San Antonio, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Daynes Eye and Lasik
🇺🇸Salt Lake City, Utah, United States