Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 17
- 主要终点
- Change From Baseline in Intraocular Pressure (IOP)
研究概览
简要总结
This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.
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
- •Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
- •Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
- •Diagnosis of chronic angle-closure glaucoma
- •Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.
排除标准
- •Known allergy or hypersensitivity to COMBIGAN®
- •Corneal abnormalities that would preclude accurate IOP readings
- •Any other active ocular disease other than glaucoma or ocular hypertension
- •Ocular surgery within the past 3 months.
研究组 & 干预措施
COMBIGAN® with Latanoprost
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
干预措施: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution (Drug)
COMBIGAN® with Latanoprost
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
干预措施: latanoprost (Drug)
结局指标
主要结局
Change From Baseline in Intraocular Pressure (IOP)
时间窗: Baseline, Week 12
IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
次要结局
- Change From Baseline in IOP(Baseline, Week 2, Week 6)
- Percentage of Responders With an IOP Reduction ≥20% From Baseline(Baseline, Week 12)