Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 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 DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
详细描述
Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.
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
- •Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
- •At least 3 months of contact lens wearing experience;
- •Less than or equal to 0.75 diopter (D) astigmatism in each eye;
- •Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
- •Monovision and/or multifocal lens wearer;
- •Routinely sleeps in habitual contact lenses.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DT1, then Infuse
Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
干预措施: Delefilcon A contact lenses (Device)
DT1, then Infuse
Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
干预措施: Kalifilcon A contact lenses (Device)
Infuse, then DT1
Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
干预措施: Delefilcon A contact lenses (Device)
Infuse, then DT1
Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.
干预措施: Kalifilcon 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 (-0/+3), 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