Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 14
- 主要终点
- Distance Visual Acuity (VA) With Study Lenses
研究概览
简要总结
The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
详细描述
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 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 weekly/monthly toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months;
- •Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
- •Able to wear contact lenses within the range of available sphere & cylinder power and axes.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Daily disposable contact lens wearers.
- •Monovision and multifocal contact lens wearers.
- •Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Distance Visual Acuity (VA) With Study Lenses
时间窗: Day 1 and Day 30, each wear period (approximately 30 days)
Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). 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 inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
次要结局
未报告次要终点