Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension
- Conditions
- Glaucoma, Open-AngleOcular Hypertension
- Interventions
- Procedure: Selective Laser TrabeculoplastyProcedure: Sham Selective Laser Trabeculoplasty
- Registration Number
- NCT02507687
- Lead Sponsor
- AbbVie
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye that require IOP lowering treatment.
- In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
- In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.
- History of previous laser trabeculoplasty
- History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
- Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
- Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) Sham Bimatoprost SR Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) Selective Laser Trabeculoplasty Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) Sham Selective Laser Trabeculoplasty Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Sham Bimatoprost SR Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Selective Laser Trabeculoplasty Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Sham Selective Laser Trabeculoplasty Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) Sham Bimatoprost SR Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met. Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) Selective Laser Trabeculoplasty Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met. Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) Sham Selective Laser Trabeculoplasty Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met. Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) Sham Bimatoprost SR Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met. Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) Selective Laser Trabeculoplasty Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met. Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) Sham Selective Laser Trabeculoplasty Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met. Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Bimatoprost SR Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye) Bimatoprost SR Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only). Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye) Bimatoprost SR Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met. Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye) Bimatoprost SR Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met.
- Primary Outcome Measures
Name Time Method Change From Baseline in Intraocular Pressure at Week 4 Baseline and 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.
Change From Baseline in Intraocular Pressure at Week 12 Baseline and 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.
Change From Baseline in Intraocular Pressure at Week 24 Baseline and 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.
- Secondary Outcome Measures
Name Time Method Time to Initial Use of Non-study IOP-lowering Treatment From first administration of study treatment to the end of study; overall median follow-up time of 728 days. 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.Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle 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 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.Change From Baseline in IOP at Weeks 8, 15, and 20 Baseline and 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.
Trial Locations
- Locations (95)
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
Scroll for more (85 remaining)Trinity Research Group /ID# 234598🇺🇸Dothan, Alabama, United States