NCT05805059已完成不适用
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Lens Handling on Removal
研究概览
简要总结
The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.
详细描述
This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Self-reports having a full eye examination in the previous two years;
- •Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears soft contact lenses, for the past 3 months minimum;
- •No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
- •No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
- •Has refractive astigmatism no higher than -0.75DC in each eye;
- •Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- •Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Has undergone refractive error surgery or intraocular surgery.
结局指标
主要结局
Lens Handling on Removal
时间窗: Collected once on day 6 at the end of wear
Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices FrequentlyMyopiaNCT05805150Coopervision, Inc.69
已完成
不适用
Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement LensMyopiaNCT01151371Johnson & Johnson Vision Care, Inc.452
已完成
不适用
Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®Refractive ErrorNCT02388763Alcon Research66
已完成
不适用
Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact LensesMyopiaNCT01362907CIBA VISION40
已完成
不适用
Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens WearersMyopiaNCT01233076CIBA VISION60