Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Mean Distance Visual Acuity (VA) With Study Lenses
研究概览
简要总结
The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.
详细描述
Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requires ADD (additional power for near vision);
- •Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
- •Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
- •Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- •Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- •Monovision contact lens wear.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Mean Distance Visual Acuity (VA) With Study Lenses
时间窗: Day 2, each wear period. A wear period was approximately 2 days.
Visual Acuity (VA) was assessed binocularly (both eyes together) with study lenses in place at a distance of 4 meters using letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR), where 0.0 logMAR equates to 20/20 Snellen (normal distance eyesight). A lower number indicates better visual acuity. No hypothesis testing is pre-specified for this endpoint.
次要结局
未报告次要终点