A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 126
- 主要终点
- Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
研究概览
简要总结
This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Glaucoma and/or ocular hypertension in both eyes
- •Requires IOP-lowering treatment in both eyes
排除标准
- •Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
- •Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
- •Use of oral, injectable or topical corticosteroids within 21 days
- •Iridectomy or laser peripheral iridotomy in the study eye within 3 months
- •Uncomplicated cataract surgery in the study eye within 6 months
- •Incisional glaucoma surgery in the study eye within 12 months
研究组 & 干预措施
Triple Combination Therapy
One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
干预措施: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution (Drug)
结局指标
主要结局
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
时间窗: Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. 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
未报告次要终点