Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 16
- 主要终点
- Least Squares Mean Distance VA (logMAR) With Study Lenses
研究概览
简要总结
The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.
详细描述
Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation 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 toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
- •Any spherical monovision and multifocal lens wearers.
- •Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Distance VA (logMAR) With Study Lenses
时间窗: Day 8 (-0/+3 days), each study lens type
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
次要结局
未报告次要终点