Effect of Clemastine Fumarate on Color Vision in Healthy Controls
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change from baseline cone contrast test score at 3 weeks
研究概览
简要总结
In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.
详细描述
Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control
排除标准
- •Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma
研究组 & 干预措施
Clemastine
This group will receive 8mg of clemastine daily.
干预措施: Clemastine fumarate (Drug)
结局指标
主要结局
Change from baseline cone contrast test score at 3 weeks
时间窗: baseline, 3 day, 3 week
Cone contrast and color vision testing to be performed at all 3 study visits
次要结局
- Change from baseline Lanthany D15 score at 3 weeks(baseline, 3 day, 3 week)
研究者
Ari Green
MD, MCR
University of California, San Francisco