This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients 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
240
Bimatoprost SR is a biodegradable, sustained-release, preservative-free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is injected into the anterior chamber via the corneal limbus using the prefilled applicator.
Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.
SLT is a laser procedure that targets the melanin, or pigment, in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method.
Change From Baseline in Intraocular Pressure at Week 4
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Week 4
Change From Baseline in Intraocular Pressure at Week 12
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Week 12
Change From Baseline in Intraocular Pressure at Week 24
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Week 24
Time to Initial Use of Non-study IOP-lowering Treatment
The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method. If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP-lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available.
Time frame: From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
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Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
Trinity Research Group /ID# 234598
Dothan, Alabama, United States
Arizona Advanced Eye Research Institute /ID# 234947
Glendale, Arizona, United States
Arizona Glaucoma Specialists /ID# 235066
Phoenix, Arizona, United States
M&M Eye Institute /ID# 235391
Prescott, Arizona, United States
Walman Eye Center /ID# 236054
Sun City, Arizona, United States
California Center for Clin Res /ID# 237412
Arcadia, California, United States
Orange County Ophthalmology /ID# 235995
Garden Grove, California, United States
Speciality Eye Care Medical Group /ID# 236001
Glendale, California, United States
Lugene Eye Institute /ID# 237042
Glendale, California, United States
Lakeside Vision Center /ID# 234971
Irvine, California, United States
...and 85 more locations
Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline, Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24
Change From Baseline in IOP at Weeks 8, 15, and 20
IOP was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis.
Time frame: Baseline and Weeks 8, 15, and 20