Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
研究概览
简要总结
The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.
详细描述
After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.
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
- Single (Outcomes Assessor)
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
- •Must sign informed consent form.
- •Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
- •Willing to wear lenses every day or at least 5 days per week 6 hours per day.
- •Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens.
- •Pregnant or lactating.
- •Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
- •Any abnormal ocular condition as specified in the protocol.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
时间窗: Day 10, each product
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
次要结局
- High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10(Day 10, each product)