Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan 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
- 129
- 试验地点
- 1
- 主要终点
- Mean change from baseline in intraocular pressure
研究概览
简要总结
The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, 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
- •Open-angle glaucoma
- •Ocular hypertension
- •Must have been on Xalatan for at least 3 months
- •VA not worse than 0.60
- •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
AL-37807
AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
干预措施: AL-37807 ophthalmic suspension, 0.1% (Drug)
AL-37807
AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
干预措施: Latanoprost ophthalmic solution (Drug)
Timolol
Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
干预措施: Timolol gel forming solution, 0.5% (Drug)
Timolol
Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
干预措施: Latanoprost ophthalmic solution (Drug)
AL-37807 vehicle
AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
干预措施: AL-37807 ophthalmic suspension, 0.1% (Drug)
AL-37807 vehicle
AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
干预措施: AL-37807 ophthalmic solution vehicle (Other)
AL-37807 vehicle
AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
干预措施: Latanoprost ophthalmic solution (Drug)
结局指标
主要结局
Mean change from baseline in intraocular pressure
时间窗: Baseline, up to 4 weeks
次要结局
未报告次要终点