Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 12
- 主要终点
- Distance VA With Study Lenses at Week 1
研究概览
简要总结
The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.
详细描述
Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact 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
盲法说明
In this single arm study, the subject will be masked to the lens type.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
- •Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
- •Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.
排除标准
- •Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
- •Monovision contact lens wear;
- •Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
结局指标
主要结局
Distance VA With Study Lenses at Week 1
时间窗: Week 1
Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.
次要结局
未报告次要终点