A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 263
- 主要终点
- Intraocular Pressure (IOP) in the Study Eye
研究概览
简要总结
This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 open-angle glaucoma or ocular hypertension
- •No use of Lumigan® in the past 3 months
排除标准
- •Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
研究组 & 干预措施
Bimatoprost 0.03%
Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
干预措施: Bimatoprost 0.03% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) in the Study Eye
时间窗: Month 3
IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog \[PGA\] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).
次要结局
- Percentage of Patients With an Adverse Event of Conjunctival Hyperemia(3 Months)