Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 238
- 主要终点
- Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
研究概览
简要总结
This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
- •No anticipated wearing of contact lenses during study
排除标准
- •Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
- •Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
- •Required regular use of other ocular medications except for occasional use of artificial tears
研究组 & 干预措施
Combigan®
One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
干预措施: brimonidine tartrate/timolol fixed combination ophthalmic solution (Drug)
Combigan®
One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
干预措施: fixed combination vehicle (Other)
Alphagan® and Timolol Concurrent
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
干预措施: brimonidine tartrate ophthalmic solution (Drug)
Alphagan® and Timolol Concurrent
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
干预措施: timolol ophthalmic solution (Drug)
结局指标
主要结局
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
时间窗: Baseline, Week 4
Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
次要结局
未报告次要终点