NCT00821002已完成2 期
An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug 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
- 32
- 主要终点
- Intraocular pressure change from baseline (mmHg)
研究概览
简要总结
The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Over 18 years
- •Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
排除标准
- •Uncontrolled medical conditions
- •Subjects who wear contact lenses
- •Subjects requiring chronic topical artificial tears, lubricants, and /or requiring any other chronic topical medications
研究组 & 干预措施
Plug placement
Experimental
干预措施: Latanoprost (Drug)
结局指标
主要结局
Intraocular pressure change from baseline (mmHg)
时间窗: 6 weeks
次要结局
- Number of subjects with adverse events(6 weeks)
研究者
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