An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects 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
- 93
- 主要终点
- Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
研究概览
简要总结
This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.
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
- Single (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
- •Ocular hypertension or glaucoma that requires treatment with medication
- •Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes
排除标准
- •History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
- •History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
- •Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
研究组 & 干预措施
bimatoprost 0.01% and hypromellose 0.3%
Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
干预措施: bimatoprost 0.01% (Drug)
bimatoprost 0.01% and hypromellose 0.3%
Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
干预措施: hypromellose 0.3% (Drug)
travatan 0.004% and timolol 0.5%
Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
干预措施: travatan 0.004% (Drug)
travatan 0.004% and timolol 0.5%
Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
干预措施: timolol 0.5% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
时间窗: Week 12 at 8 AM, 12 PM, and 4 PM
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.
次要结局
未报告次要终点