NCT01481051已完成2 期
PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 12
- 主要终点
- IOP change from baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female at least 18 years old
- •Diagnosis of bilateral open angle glaucoma or ocular hypertension
- •Unmedicated IOP must be ≥22mm Hg
排除标准
- •Any significant vision loss in the last year
- •No contact lens use for the length of the study
- •Abnormal eye lids, eye infection, or diseases to the eye
- •Recent eye surgery
- •Uncontrolled medication conditions
结局指标
主要结局
IOP change from baseline
时间窗: 12 weeks to baseline
次要结局
未报告次要终点
研究者
研究点 (12)
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