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

Completed · Phase 3

Conditions studied: Blepharitis

In brief

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.

Key facts

Study ID

NCT01408082

Run by

Sun Pharmaceutical Industries Limited

People needed

917

Starts

2011-10-01

Expected to finish

2013-06-01

Last updated by the study team

2021-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Shasta Eye Medical Group, Inc. — Redding, California, United States
• San Diego Eye and Laser Center — San Diego, California, United States
• West Coast Eye Care Associates — San Diego, California, United States
• Florida Eye Microsurgicial Institute, Inc. — Boynton Beach, Florida, United States
• ZASA Clinical Research, LLC — Boynton Beach, Florida, United States
• Magruder Eye Institute — Orlando, Florida, United States
• Vision Eye Care Center — Palm Springs, Florida, United States
• International Research Center — Tampa, Florida, United States
• Richard Eiferman, MD — Louisville, Kentucky, United States
• Lakeview Optical — Gretna, Louisiana, United States
• Center for Sight, Inc. — Fall River, Massachusetts, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Comprehensive Eye Care Ltd — Washington, Missouri, United States
• Abrams Eye Institute — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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