Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Mean Intraocular Pressure
研究概览
简要总结
The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Age related
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Travoprost 0.0008%
Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
干预措施: Travoprost ophthalmic solution, 0.0008% (Drug)
Travoprost 0.001%
Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
干预措施: Travoprost ophthalmic solution, 0.001% (Drug)
Travoprost 0.0012%
Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
干预措施: Travoprost ophthalmic solution, 0.0012% (Drug)
TRAVATAN + Vehicle
TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks
干预措施: TRAVATAN (Drug)
TRAVATAN + Vehicle
TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks
干预措施: Vehicle (Other)
Vehicle
Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
干预措施: Vehicle (Other)
结局指标
主要结局
Mean Intraocular Pressure
时间窗: Up to 2 weeks
次要结局
未报告次要终点