Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 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
- 104
- 主要终点
- Mean change from baseline in IOP
研究概览
简要总结
The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 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
- •Diagnosed with open-angle glaucoma or ocular hypertension.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Females of childbearing potential.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-39256
AL-39256 Ophthalmic Suspension, 1%, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.
干预措施: AL-39256 Ophthalmic Suspension, 1% (Drug)
XALATAN
Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks.
干预措施: Latanoprost Ophthalmic Solution, 0.005% (Drug)
XALATAN
Latanoprost Ophthalmic Solution, 0.005%, 1 drop in the study eye(s) at 8 PM from the evening bottle (morning bottle contained vehicle and was dosed 1 drop in the study eye(s) at 8 AM) for 4 weeks.
干预措施: Vehicle (Drug)
Vehicle
Inactive ingredients, 1 drop in the study eye(s) at 8 AM from the morning bottle and 1 drop in the study eye(s) at 8 PM from the evening bottle for 4 weeks.
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean change from baseline in IOP
时间窗: Week 4
次要结局
未报告次要终点