Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Serum Formate Levels over baseline
研究概览
简要总结
This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.
详细描述
This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females
排除标准
- •no ocular diseases
研究组 & 干预措施
Open label
Each participant will be treated with three 3900 mg doses of calcium formate on each study day (i.e., days 1-14).
干预措施: calcium formate (Drug)
结局指标
主要结局
Change in Serum Formate Levels over baseline
时间窗: Up to 15 days
To test for accumulation of formate, morning blood samples for determination of formate will be obtained at screening, prior to administration of the first dose of calcium formate on Study Days 1, 2, 3, and 8 and on day 15. Blood samples for determination of formate will also be obtained approximately 40-60 minutes after ingestion of the second dose on Study Days 1, 2 and 3.
Vision Testing (refraction) over baseline
时间窗: Up to 15 days
Participants will be refracted at baseline and the resultant lens correction will be used for testing visual acuity at all subsequent visits. If a participant's visual acuity drops 10 letters or more at any visit, the participant will be re-refracted and the visual acuity will be tested again with the new lens correction in place.
次要结局
- Change in Visual Fields over baseline(Up to 15 days)
- Change in 100 Hue Vision Testing results over baseline(Up to 15 days)
- Change in ERG/VEP over baseline(Up to 15 days)
- Change in Visual Acuity over baseline(Up to 15 days)
- Fundus Photography(Up to 15 days)