NCT02207491已完成3 期
A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% Compared to Timolol Maleate Ophthalmic Solution, 0.5% in Patients With Elevated Intraocular Pressure
Aerie Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic Solution, 0.5%
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AR-13324 Ophthalmic Solution 0.02% & Placebo
Experimental
1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
干预措施: AR-13324 Ophthalmic Solution 0.02% (Drug)
AR-13324 Ophthalmic Solution 0.02% & Placebo
Experimental
1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
干预措施: Placebo (Other)
Timolol maleate Ophthalmic Solution 0.5% BID
Active Comparator
1 drop Timolol maleate twice daily (BID) in the morning (AM) & evening (PM) in both eyes (OU)
干预措施: Timolol maleate Ophthalmic Solution 0.5% BID (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 3 months
The primary efficacy outcome is mean IOP
次要结局
- Extent of Exposure(3 months)
研究者
研究点 (1)
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