NCT00820300已完成2 期
An Open-Label, Phase 2 Study 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
- 113
- 主要终点
- IOP change from baseline
研究概览
简要总结
The purpose of this study is to determine if the Punctal Plug Delivery System is safe and effective in controlling intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 yrs with ocular hypertension or open-angle glaucoma
- •Subjects who have a best-corrected visual acuity of 20/100 or better.
排除标准
- •Subjects who wear contact lenses.
- •Uncontrolled medical conditions
- •Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
- •Subjects who have a history of chronic or recurrent inflammatory eye disease.
研究组 & 干预措施
Punctal plug
Experimental
干预措施: Latanoprost-PPDS (Drug)
结局指标
主要结局
IOP change from baseline
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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