Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 586
- 主要终点
- Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
研究概览
简要总结
The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular hypertension or chronic glaucoma
- •Patient requires IOP-lowering therapy in both eyes
排除标准
- •Uncontrolled medical conditions
- •Hypersensitivity to study medications
研究组 & 干预措施
1
bimatoprost 0.03% eye drops
干预措施: bimatoprost 0.03% eye drops (Drug)
2
latanoprost 0.005% eye drops
干预措施: latanoprost 0.005% eye drops (Drug)
结局指标
主要结局
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
时间窗: Baseline, Week 12
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
时间窗: Baseline, Week 18
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
次要结局
未报告次要终点