Clinical Comparison of Two Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 8
- 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™ contact lenses to Clariti® 1 day contact lenses.
详细描述
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. 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 wearer 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.
- •Possess spectacles and 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 one of the days (day prior to each week 1 visit).
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
- •Any monovision and multifocal lens wearers.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
PRECISION1, then Clariti 1-Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
干预措施: Somofilcon A contact lenses (Device)
PRECISION1, then Clariti 1-Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
干预措施: Verofilcon A contact lenses (Device)
Clariti 1-Day, then PRECISION1
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
干预措施: Verofilcon A contact lenses (Device)
Clariti 1-Day, then PRECISION1
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
干预措施: Somofilcon A contact lenses (Device)
结局指标
主要结局
Least Squares Mean Distance VA (logMAR) With Study Lenses
时间窗: Day 8, 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