A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 112
- 主要终点
- Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
研究概览
简要总结
This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ocular hypertension or glaucoma
- •Requires intraocular pressure (IOP)-lowering therapy
排除标准
- •Cataract surgery in one eye
- •Ocular laser or intraocular surgery within 6 months
- •Refractive surgery in either eye
- •Anticipated use of contact lenses during the study
- •Expected use of artificial tears during the study
研究组 & 干预措施
Fixed-Combination Bimatoprost/Brimonidine
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
干预措施: Fixed-Combination Bimatoprost/Brimonidine (Drug)
Bimatoprost Ophthalmic Solution 0.01% and Vehicle
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
干预措施: Bimatoprost Ophthalmic Solution 0.01% (Drug)
Bimatoprost Ophthalmic Solution 0.01% and Vehicle
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
干预措施: Vehicle Ophthalmic Solution (Drug)
Brimonidine Tartrate Ophthalmic Solution 0.2%
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
干预措施: Brimonidine Tartrate Ophthalmic Solution 0.2% (Drug)
结局指标
主要结局
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
时间窗: Baseline, Day 42
IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
次要结局
- Change From Baseline in Average Eye Mean Diurnal IOP(Baseline, Day 14, Day 28)
- Average Eye Mean Diurnal IOP(Day 14, Day 28, Day 42)