Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 16
- 主要终点
- Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1
研究概览
简要总结
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
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 14 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 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
- •Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- •Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Currently pregnant or lactating.
- •History of amblyopia, strabismus, or binocular vision abnormalities.
- •Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
- •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 Week 1
时间窗: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) 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). No hypothesis testing was pre-specified for this endpoint.
次要结局
未报告次要终点