A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 173
- 主要终点
- Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older.
- •Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
- •Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History of chronic or recurrent severe inflammatory eye disease.
- •History of ocular infection or ocular inflammation within the past three months in either eye.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Travoprost/Timolol
One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months
干预措施: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (Drug)
Travoprost/Timolol
One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months
干预措施: Timolol Vehicle (Other)
Xalatan + Timolol 0.5%
One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months
干预措施: Latanoprost 0.005% Ophthalmic Solution (XALATAN) (Drug)
Xalatan + Timolol 0.5%
One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months
干预措施: Timolol 0.5% Ophthalmic Solution (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline
时间窗: 3 months
次要结局
未报告次要终点