A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
- Conditions
- GlaucomaOpen-Angle Ocular Hypertension
- Interventions
- Procedure: Selective Laser TrabeculoplastyProcedure: Sham Selective Laser Trabeculoplasty
- Registration Number
- NCT02636946
- Lead Sponsor
- Allergan
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.
- Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
- Enrollment in other studies using Bimatoprost SR.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Sham Bimatoprost SR 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. SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Selective Laser Trabeculoplasty 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. SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Sham Selective Laser Trabeculoplasty 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. Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Selective Laser Trabeculoplasty 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. Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Sham Selective Laser Trabeculoplasty 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. SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Bimatoprost SR 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. Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Bimatoprost SR 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. Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Sham Bimatoprost SR 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in IOP at Week 12 Baseline (prior to treatment) to Week 12 IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
Change From Baseline in IOP at Week 4 Baseline (prior to treatment) to Week 4 IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses.
Intraocular Pressure (IOP) at Baseline Baseline (prior to treatment) IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Change From Baseline in Intraocular Pressure (IOP) at Week 24 Baseline (prior to treatment) to Week 24 IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.
- Secondary Outcome Measures
Name Time Method Change From Baseline in IOP at Weeks 8, 15, and 20 Baseline (prior to treatment) to Weeks 8, 15 and 20 IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator First treatment to end of study (up to 525 days) Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP 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 IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3.
Trial Locations
- Locations (33)
Wolstan & Goldberg Eye Associates
🇺🇸Torrance, California, United States
Asheville Eye Associates
🇺🇸Asheville, North Carolina, United States
Glostrup Hospital
🇩🇰Glostrup, Hovedstaden, Denmark
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Eye Center South
🇺🇸Dothan, Alabama, United States
Shasta Eye Medical Group, Inc.
🇺🇸Redding, California, United States
Walman Eye Center
🇺🇸Chandler, Arizona, United States
Coastal Research Associates, LLC
🇺🇸Roswell, Georgia, 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
Fraser Eye Center
🇺🇸Fraser, Michigan, United States
Ophthalmic Consultants of Long Island
🇺🇸Lynbrook, New York, 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
Vistar Eye Center
🇺🇸Roanoke, Virginia, United States
Marsden Eye Specialists
🇦🇺Parramatta, New South Wales, Australia
Centrum Diagnostykii Mikrochirurgii Oka LENS ul.
🇵🇱Olsztyn, Warmian-Masurian Voivodeship, Poland
CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie
🇫🇷Bordeaux, France
Prywatna Klinika Okulistyczna OFTALMIKA
🇵🇱Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch
🇷🇺Novosibirsk, Russian Federation
Ophthalmic Clinical Hospital V.P. Vyhodtseva
🇷🇺Omsk, Russian Federation
Centro de Oftalmologia Barraquer
🇪🇸Barcelona, Spain
Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand
Thammasat University Hospital
🇹🇭Pathumthani, Thailand
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
DCT- Shah Research
🇺🇸Mission, Texas, United States
Galanis Cataract and Laser Eye Center
🇺🇸Saint Louis, Missouri, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
James D. Branch MD
🇺🇸Winston-Salem, North Carolina, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
Singapore National Eye Centre
🇸🇬Singapore, Singapore