Clinical Performance Evaluation 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
- 95
- 试验地点
- 22
- 主要终点
- Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses
研究概览
简要总结
The purpose of this study is to evaluate on-eye clinical performance of the investigational contact lenses following 30 days of wear in the intended population.
详细描述
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 30 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 5 office visits. The total duration of study participation is approximately 66 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Habitual wearer of biweekly/monthly replacement soft multifocal or multifocal toric contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- •Manifest cylinder equal to or greater than 0.75 diopter (D) in each eye at Screening;
- •Willing to not use readers while wearing study contact lenses for duration of the study;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- •Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- •Monovision contact lens wearers and wearers of contact lens in one eye only;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Binocular Visual Acuity at Distance (4 Meters) at Day 30 With Study Lenses
时间窗: Day 30 (-2/+1) of each wear period. A wear period was 30 days (-2/+1) according to randomization assignment.
Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen).
次要结局
未报告次要终点