Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Mean Distance Visual Acuity (logMAR) With Study Lenses
研究概览
简要总结
The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.
详细描述
Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).
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
- •Able to understand and sign an approved Informed Consent form;
- •Willing and able to attend all scheduled study visits as required by the protocol;
- •Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Current or prior Biofinity contact lens wearer in the past 3 months;
- •Monovision contact lens wearer;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Distance Visual Acuity (logMAR) With Study Lenses
时间窗: Day 1, Day 30 after 6-8 hours of wear, each product
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). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
次要结局
未报告次要终点