Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 235
- 主要终点
- The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
研究概览
简要总结
This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
- •Eye pressure lowering topical medications are not working
- •Visual acuity is at least 0.2 in each eye
排除标准
- •Uncontrolled systemic disease
- •Any other active eye disease other than glaucoma or ocular hypertension
- •Significant visual field loss or evidence of progressive visual field loss within the last year
- •Anticipated wearing of contact lenses during the study
- •Required chronic use of other ocular medications during the study
- •Eye surgery or laser treatment within 12 weeks prior to study enrollment
研究组 & 干预措施
0.03% Bimatoprost/0.5% Timolol in Same Bottle
Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
干预措施: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution (Drug)
0.03% Bimatoprost and 0.5% Timolol in Separate Bottles
Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
干预措施: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution (Drug)
结局指标
主要结局
The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
时间窗: Baseline, Week 4
The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.
次要结局
未报告次要终点