Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 121
- 主要终点
- Mean Diurnal Intraocular Pressure (IOP) at Week 12
研究概览
简要总结
Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.
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
- •Diagnosed with glaucoma or ocular hypertension.
- •Visual Acuity 20/100 or better in both eyes
排除标准
- •Any active ocular disease
- •History of any intraocular surgery or glaucoma laser surgery within 3 months
- •Contraindication to pupil dilation
- •Use of topical, periorbital, intravitreal, or systemic steroid within 3 months
研究组 & 干预措施
Combigan® + Lumigan®
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
干预措施: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution (Drug)
Lumigan®
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
干预措施: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops (Drug)
结局指标
主要结局
Mean Diurnal Intraocular Pressure (IOP) at Week 12
时间窗: Week 12
Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.
次要结局
未报告次要终点