A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 95
- 主要终点
- Change From Baseline in Intraocular Pressure at Week 4
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)
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).
干预措施: Bimatoprost SR (Drug)
Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)
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).
干预措施: Sham Bimatoprost SR (Drug)
Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)
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).
干预措施: Selective Laser Trabeculoplasty (Procedure)
Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)
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).
干预措施: Sham Selective Laser Trabeculoplasty (Procedure)
Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
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).
干预措施: Bimatoprost SR (Drug)
Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
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).
干预措施: Sham Bimatoprost SR (Drug)
Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
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).
干预措施: Selective Laser Trabeculoplasty (Procedure)
Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
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).
干预措施: Sham Selective Laser Trabeculoplasty (Procedure)
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)
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.
干预措施: Bimatoprost SR (Drug)
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)
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.
干预措施: Sham Bimatoprost SR (Drug)
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)
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.
干预措施: Selective Laser Trabeculoplasty (Procedure)
Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)
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.
干预措施: Sham Selective Laser Trabeculoplasty (Procedure)
Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)
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.
干预措施: Bimatoprost SR (Drug)
Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)
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.
干预措施: Sham Bimatoprost SR (Drug)
Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)
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.
干预措施: Selective Laser Trabeculoplasty (Procedure)
Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)
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.
干预措施: Sham Selective Laser Trabeculoplasty (Procedure)
结局指标
主要结局
Change From Baseline in Intraocular Pressure at Week 4
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- 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)
- Change From Baseline in IOP at Weeks 8, 15, and 20(Baseline and Weeks 8, 15, and 20)