Clinical Performance of Two Daily Disposable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 16
- 主要终点
- Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
研究概览
简要总结
The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.
详细描述
Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- •Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- •Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- •Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
- •Monovision and multifocal lens wear.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
时间窗: Day 8 (-0/+3 days), each study lens type
Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
次要结局
未报告次要终点