24-hour IOP-lowering Effect of 0.01% Bimatoprost
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Nocturnal Intraocular Pressure (IOP) Change
研究概览
简要总结
This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension
详细描述
Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).
Design Prospective, open-label experimental study.
Setting Single tertiary ophthalmic clinic.
Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).
Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary open-angle glaucoma or ocular hypertension
排除标准
- •Women of childbearing potential previous glaucoma surgery presence of other eye disease
研究组 & 干预措施
0.01% bimatoprost
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
干预措施: 0.01% bimatoprost (Drug)
结局指标
主要结局
Nocturnal Intraocular Pressure (IOP) Change
时间窗: 4 weeks
Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.
次要结局
未报告次要终点
研究者
John Liu, PhD
Adjunct Professor
University of California, San Diego