Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Lens Wettability
研究概览
简要总结
The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.
详细描述
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 18 years of age 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;
- •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;
- •Habitually wears one of the study contact lenses;
- •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
stenfilcon A - (Test lens)
Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.
干预措施: stenfilcon A - (Test lens) (Device)
stenfilcon A - (Test lens)
Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.
干预措施: kalifilcon A - (Control Lens) (Device)
kalifilcon A - (Control Lens)
Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.
干预措施: stenfilcon A - (Test lens) (Device)
kalifilcon A - (Control Lens)
Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.
干预措施: kalifilcon A - (Control Lens) (Device)
结局指标
主要结局
Lens Wettability
时间窗: 1 week
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Lens Wettability
时间窗: Baseline - after 2 hours of lens wear
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time \<\< blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
次要结局
未报告次要终点