NCT00650702已完成2 期
A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
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
- 36
- 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 Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
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
- 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 yrs with open-angle glaucoma or ocular hypertension
- •Subjects who have a best-corrected visual acuity of 20/100 or better.
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.
- •Subjects who have a history of chronic or recurrent inflammatory eye disease.
研究组 & 干预措施
1
Experimental
Low Latanoprost-PPDS
干预措施: Latanoprost-PPDS (Drug)
2
Experimental
Medium Latanoprost-PPDS
干预措施: Latanoprost-PPDS (Drug)
3
Experimental
High Latanoprost-PPDS
干预措施: Latanoprost-PPDS (Drug)
结局指标
主要结局
IOP change from baseline
时间窗: 12 Weeks
次要结局
未报告次要终点
研究者
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