NCT04535310已完成不适用
Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)
研究概览
简要总结
This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a current spherical contact lens wearer with longs days of lens wear.
- •Distance visual acuity of 20/25 or better with current contact lenses.
- •Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
- •Recent eye exam within the past year.
- •Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
- •Ability to give informed consent.
- •Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.
排除标准
- •No current ocular inflammation or infection as assessed by the study investigator.
结局指标
主要结局
Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)
时间窗: Up to 14 days
Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.
次要结局
未报告次要终点
研究者
Jennifer Fogt
Associate Professor Clinical
Ohio State University
研究点 (2)
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