NCT01481077已完成2 期
PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 11
- 主要终点
- IOP change from baseline
研究概览
简要总结
The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).
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
- 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 medical conditions
研究组 & 干预措施
Treatment A
Experimental
干预措施: Latanoprost-PPDS (Drug)
Treatment B
Experimental
干预措施: Latanoprost-PPDS (Drug)
Treatment C
Experimental
干预措施: Latanoprost-PPDS (Drug)
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 (11)
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