Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 81
- 主要终点
- Change From Baseline in Average Intraocular Pressure (IOP)
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary open-angle glaucoma that has never been treated
- •Visual Acuity 20/60 or better in each eye
排除标准
- •Eye surgery within 3 months
- •Any refractive eye surgery
- •Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
- •Eye inflammation or eye infection within 3 months
- •Eye trauma within 6 months
- •Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
研究组 & 干预措施
bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
干预措施: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (Drug)
latanoprost 0.005% ophthalmic solution
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
干预措施: latanoprost 0.005% ophthalmic solution (Drug)
结局指标
主要结局
Change From Baseline in Average Intraocular Pressure (IOP)
时间窗: Baseline, Month 3
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
次要结局
- Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading(Baseline, Month 3)
- Change From Baseline IOP(Baseline, Month 3)
- Percentage of Patients Reaching a Predefined Target Pressure Threshold(Baseline, Month 3)
- Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading(Baseline, Month 3)