Clinical Comparison 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
- 153
- 试验地点
- 22
- 主要终点
- Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
研究概览
简要总结
The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).
详细描述
Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 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 wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- •Able to wear contact lenses within a range of sphere & cylinder power and axes.
- •Willing to NOT use rewetting/lubricating drops at any time during the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Current or previous P1fA and MDT habitual lens wearers.
- •Monovision and multifocal lens wearers.
- •Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
时间窗: Day 8 of each study lens type worn during the corresponding crossover period
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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
次要结局
未报告次要终点