A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Eye Center South, Dothan, Alabama, 36301 | Status Not Available | |
Location Arizona Eye Center, Chandler, Arizona, 85224 | Status Not Available | |
Location Walman Eye Center, Chandler, Arizona, 85225 | Status Not Available | |
Location Shasta Eye Medical Group, Inc., Redding, California, 96002 | Status Not Available | |
Location Wolstan & Goldberg Eye Associates, Torrance, California, 90505 | Status Not Available | |
Location Eye Associates of Colorado Springs, Colorado Springs, Colorado, 80909 | Status Not Available | |
Location West Coast Eye Institute, Lecanto, Florida, 34461 | Status Not Available | |
Location Emory University Eye Center, Atlanta, Georgia, 30322 | Status Not Available | |
Location Coastal Research Associates, LLC, Roswell, Georgia, 30076 | Status Not Available | |
Location The Eye Care Institute, Louisville, Kentucky, 40206 | Status Not Available | |
Location Fraser Eye Center, Fraser, Michigan, 48026 | Status Not Available | |
Location Galanis Cataract and Laser Eye Center, Saint Louis, Missouri, 63119 | Status Not Available | |
Location Ophthalmic Consultants of Long Island, Lynbrook, New York, 11563 | Status Not Available | |
Location Asheville Eye Associates, Asheville, North Carolina, 28803 | Status Not Available | |
Location James D. Branch MD, Winston-Salem, North Carolina, 27101 | Status Not Available | |
Location Bergstrom Eye Research, LLC, Fargo, North Dakota, 58103 | Status Not Available | |
Location Scott & Christie and Associates, PC, Cranberry Township, Pennsylvania, 16066 | Status Not Available | |
Location The Cataract & Glaucoma Center, El Paso, Texas, 79902 | Status Not Available | |
Location DCT- Shah Research, Mission, Texas, 78572 | Status Not Available | |
Location San Antonio Eye Center, San Antonio, Texas, 78215 | Status Not Available | |
Location Vistar Eye Center, Roanoke, Virginia, 24016 | Status Not Available | |
Location CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie, Bordeaux, 33076 | Status Not Available | |
Location Centro de Oftalmologia Barraquer, Barcelona, 8021 | Status Not Available | |
Location Hospital Clinico San Carlos, Madrid, 28040 | Status Not Available |
This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
Intraocular Pressure (IOP) at Baseline
Time Frame: Baseline (prior to treatment)
Change From Baseline in IOP at Week 4
Time Frame: Baseline (prior to treatment) to Week 4
Change From Baseline in IOP at Week 12
Time Frame: Baseline (prior to treatment) to Week 12
Change From Baseline in Intraocular Pressure (IOP) at Week 24
Time Frame: Baseline (prior to treatment) to Week 24
Change From Baseline in IOP at Weeks 8, 15, and 20
Time Frame: Baseline (prior to treatment) to Weeks 8, 15 and 20
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
Time Frame: First treatment to end of study (up to 525 days)
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
Time Frame: Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20
Interventions:
- Drug: Bimatoprost SR
- Drug: Bimatoprost SR
- Drug: Sham Bimatoprost SR
- Drug: Sham Bimatoprost SR
- Procedure: Selective Laser Trabeculoplasty
- Procedure: Selective Laser Trabeculoplasty
- Procedure: Sham Selective Laser Trabeculoplasty
- Procedure: Sham Selective Laser Trabeculoplasty
Enrollment:
144
Available Documents
FaFilePdfUnmappedFaFilePdfUnmappedFaFilePdfScientific Result Summary (English)FaFilePdfPlain Language Summary (English)FaFilePdfPlain Language Summary (Danish)FaFilePdfPlain Language Summary (French)FaFilePdfPlain Language Summary (Polish)FaFilePdfPlain Language Summary (Russian)Additional Information
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