A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 10
- 主要终点
- Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
研究概览
简要总结
The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.
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, Investigator)
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
- •Written informed consent
- •Primary open-angle glaucoma or ocular hypertension in both eyes
- •Best-corrected distance vision of 20/80 or better
- •Stable visual field
- •corneal thickness between 490-620 micrometers
排除标准
- •Cup-to-disc ratio greater than 0.8
- •significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
- •laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
- •past history of corneal refractive surgery
- •past history of any incisional surgery for glaucoma at any time
- •corneal abnormalities that would interfere with tonometry readings
- •current participation in an investigational drug or device study or participation in such a study within 30 days of screening
- •Inability to accurately evaluate the retina
研究组 & 干预措施
13 mg Bimatoprost Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.
干预措施: Bimatoprost (Drug)
13 mg Bimatoprost Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.
干预措施: Placebo Eye Drops (Drug)
13 mg Bimatoprost Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.
干预措施: Placebo Ocular Insert (Device)
Timolol 0.5% + Placebo Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.
干预措施: Timolol 0.5% (Drug)
Timolol 0.5% + Placebo Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.
干预措施: Placebo Ocular Insert (Device)
结局指标
主要结局
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
时间窗: Baseline (Day 0) to Week 2
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
时间窗: Baseline (Day 0) to Week 6
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
时间窗: Baseline (Day 0) to Week 12
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
次要结局
- Change From Baseline in IOP at Month 4(Baseline (Day 1) to Month 4)
- Change From Baseline in IOP at Month 5(Baseline (Day 0) to Month 5)
- Change From Baseline in IOP at Month 6(Baseline (Day 0) to Month 6)