Evaluation of Wear Experience With PRECISION1® Toric Contact Lenses on Long Lens Wear Days
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
研究概览
简要总结
This study is evaluating the wear experience of a daily toric 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 current soft toric contact lens wearers with longs days of lens wear within the parameters of Precision1® lenses available.
- •Distance visual acuity of 20/25 or better with current lenses.
- •Recent eye exam in the last year.
- •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).
- •Ability to give informed consent.
- •Must have a working smart phone or device and be willing to receive and respond to texts and/or emails.
- •Willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between Visits 2 and 3.
排除标准
- •Current ocular inflammation or infection as assessed by the study investigator.
- •Currently pregnant, lactating, or planning to become pregnant during the course of the study.
结局指标
主要结局
Subjective Vision in Contact Lenses Assessed Using a 1 to 10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
时间窗: Assessment is taken at the 16 hour of wear time point in a single day, after up to 14 days of wear.
1 describes poor experience, and 10 describes excellent experience.
Subjective Comfort on a 1-10 Scale After 16 Hours of Wear in One Day (After up to 14 Days of Wear)
时间窗: Taken at the 16 hour of wear time point in a single day, after up to 14 days of wear Up to 14 days
1 describes poor experience, and 10 describes excellent experience.
次要结局
未报告次要终点
研究者
Jennifer Fogt
Associate Professor of Clinical Optometry
Ohio State University