NCT01379560已完成2 期
A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration
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
- 33
- 试验地点
- 1
- 主要终点
- Change in choroidal blood flow
研究概览
简要总结
The purpose of this study is to determine the pharmacodynamics of ocular blood flow measurements with multiple drop unoprostone isopropyl administration versus placebo in subjects with dry age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years at screening
- •Ametropy ≤ 3 diopters
- •Clear ocular media
- •Visual acuity in the study eye > 20/40
排除标准
- •Presence of any ocular condition in the study eye (other than AMD) that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study
- •Blood donation during the previous 3 weeks
- •Current smoker or a history of smoking within 5 years of enrollment
- •Treatment with protocol-specified prohibited concomitant medications
- •Prior exposure to Rescula (unoprostone isopropyl) and or a known sensitivity to any of the components of the study medication (e.g. benzalkonium chloride)
研究组 & 干预措施
unoprostone isopropyl (3 drop)
Experimental
干预措施: unoprostone isopropyl (Drug)
unoprostone isopropyl (2 drop)
Experimental
干预措施: unoprostone isopropyl (Drug)
结局指标
主要结局
Change in choroidal blood flow
时间窗: In total 6 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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