Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- Mean Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to determine the safety and IOP-lowering ability of a 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 or ocular hypertension.
- •LogMAR visual acuity not worse than 0.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Clinically relevant ophthalmic or systemic conditions.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-12182 0.003%
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
干预措施: AL-12182 0.003% Ophthalmic Solution (Drug)
AL-12182 Solution Vehicle
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
干预措施: AL-12182 Ophthalmic Solution Vehicle (Other)
Latanoprost
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
AL-12182 0.01%
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
干预措施: AL-12182 0.01% Ophthalmic Solution (Drug)
AL-12182 0.03%
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
干预措施: AL-12182 0.03% Ophthalmic Solution (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP)
次要结局
未报告次要终点