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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
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).
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 administered on Day 1.
Intraocular Pressure (IOP) at Baseline
IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.
Time frame: Baseline (prior to treatment)
Change From Baseline in IOP at 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.
Time frame: Baseline (prior to treatment) to Week 4
Change From Baseline in IOP at 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.
Time frame: Baseline (prior to treatment) to Week 12
Change From Baseline in Intraocular Pressure (IOP) at 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.
Time frame: Baseline (prior to treatment) to Week 24
Change From Baseline in IOP at 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 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
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Sham Selective Laser Trabeculoplasty administered on Day 1.
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
...and 23 more locations
Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.
Time frame: First treatment to end of study (up to 525 days)
Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
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.
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