A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT ID: NCT02636946
Last Updated: 2022-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
144 participants
INTERVENTIONAL
2016-02-24
2021-01-26
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
TRIPLE
Study Groups
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SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
Bimatoprost SR
Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).
Sham Bimatoprost SR
Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).
Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty administered on Day 1.
Sham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
Bimatoprost SR
Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).
Sham Bimatoprost SR
Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).
Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty administered on Day 1.
Sham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.
Interventions
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Bimatoprost SR
Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).
Sham Bimatoprost SR
Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).
Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty administered on Day 1.
Sham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Enrollment in other studies using Bimatoprost SR.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Margot Goodkin
Role: STUDY_DIRECTOR
Allergan
Locations
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Eye Center South
Dothan, Alabama, United States
Arizona Eye Center
Chandler, Arizona, United States
Walman Eye Center
Chandler, Arizona, United States
Shasta Eye Medical Group, Inc.
Redding, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Eye Associates of Colorado Springs
Colorado Springs, Colorado, United States
West Coast Eye Institute
Lecanto, Florida, United States
Emory University Eye Center
Atlanta, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
The Eye Care Institute
Louisville, Kentucky, United States
Fraser Eye Center
Fraser, Michigan, United States
Galanis Cataract and Laser Eye Center
St Louis, Missouri, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Asheville Eye Associates
Asheville, North Carolina, United States
James D. Branch MD
Winston-Salem, North Carolina, United States
Bergstrom Eye Research, LLC
Fargo, North Dakota, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
The Cataract & Glaucoma Center
El Paso, Texas, United States
DCT- Shah Research
Mission, Texas, United States
San Antonio Eye Center
San Antonio, Texas, United States
Vistar Eye Center
Roanoke, Virginia, United States
Marsden Eye Specialists
Parramatta, New South Wales, Australia
Glostrup Hospital
Glostrup Municipality, Capital Region, Denmark
CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie
Bordeaux, , France
Prywatna Klinika Okulistyczna OFTALMIKA
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Diagnostykii Mikrochirurgii Oka LENS ul.
Olsztyn, Warmian-Masurian Voivodeship, Poland
S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch
Novosibirsk, , Russia
Ophthalmic Clinical Hospital V.P. Vyhodtseva
Omsk, , Russia
Singapore National Eye Centre
Singapore, , Singapore
Centro de Oftalmologia Barraquer
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital
Chiang Mai, , Thailand
Thammasat University Hospital
Pathum Thani, , Thailand
Countries
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References
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Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2015-003631-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
192024-095
Identifier Type: -
Identifier Source: org_study_id
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