Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 20
- 主要终点
- Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
研究概览
简要总结
The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.
详细描述
Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 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
- •Current wearer of a commercial spherical weekly/monthly soft contact lenses 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 in each eye.
- •Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Monovision or multifocal lens wearer.
- •Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
- •Routinely sleeps in habitual contact lenses.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
时间窗: Day 30, each study lens type
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
次要结局
未报告次要终点