Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 4
- 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 lenses.
详细描述
This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in 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
- 否
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;
- •Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
- •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.
研究组 & 干预措施
Control Lens, Then Test Lens
Participants will wear control lenses for one week and then crossover to test lenses for one week.
干预措施: Test Lens (senofilcon A) (Device)
Test Lens, Then Control Lens
Participants will wear test lenses for one week and then crossover to control lenses for one week.
干预措施: Control Lens (stenfilcon A) (Device)
Test Lens, Then Control Lens
Participants will wear test lenses for one week and then crossover to control lenses for one week.
干预措施: Test Lens (senofilcon A) (Device)
Control Lens, Then Test Lens
Participants will wear control lenses for one week and then crossover to test lenses for one week.
干预措施: Control Lens (stenfilcon A) (Device)
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
Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)
次要结局
未报告次要终点