Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
NCT ID: NCT01408082
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
917 participants
INTERVENTIONAL
2011-10-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ISV-502
ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azithromycin and Dexamethasone twice daily for 2 weeks
AzaSite
Azasite
Azasite twice daily for 2 weeks
Dexamethasone
Dexamethasone
Dexamethasone twice daily for 2 weeks
Vehicle
Vehicle
Vehicle twice daily for 2 weeks
Interventions
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ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Azithromycin and Dexamethasone twice daily for 2 weeks
Azasite
Azasite twice daily for 2 weeks
Dexamethasone
Dexamethasone twice daily for 2 weeks
Vehicle
Vehicle twice daily for 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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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
Nevada Eye Care Professionals
Las Vegas, Nevada, United States
Eye Care Associates of Nevada
Sparks, Nevada, United States
David Ringel, OD PA
Sewell, New Jersey, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
Ophthalmic Consultants of Long Island
Valley Stream, New York, United States
South Shore Eye Care
Wantagh, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
James Branch, MD
Winston-Salem, North Carolina, United States
Eye Care Associates of Greater Cincinnati, Inc.
Cincinnati, Ohio, United States
Eye Care Associates of Greater Cincinnati, Inc.
Fairfield, Ohio, United States
Eye Care Associates of Greater Cincinnati, Inc.
Madeira, Ohio, United States
Roseburg Research Associates, LLC
Roseburg, Oregon, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Research Across America @ Wyomissing Optometric Center Inc
Wyomissing, Pennsylvania, United States
Total Eye Care, PA
Memphis, Tennessee, 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
Countries
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References
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Hosseini K, Bourque LB, Hays RD. Development and evaluation of a measure of patient-reported symptoms of Blepharitis. Health Qual Life Outcomes. 2018 Jan 11;16(1):11. doi: 10.1186/s12955-018-0839-5.
Other Identifiers
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C-10-502-004
Identifier Type: -
Identifier Source: org_study_id