Performance Evaluation of Two Daily Disposable Toric 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
- 48
- 试验地点
- 4
- 主要终点
- Overall Ease of Lens Handling
研究概览
简要总结
The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.
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 toric 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 12 hours a day, 7 days a week;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
- •Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
- •Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
- •Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
- •Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters
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
Lens A
daily disposable soft contact lens - test lens
Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.
干预措施: Lens A (Device)
Lens A
daily disposable soft contact lens - test lens
Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.
干预措施: Lens B (Device)
Lens B
daily disposable soft contact lens - control lens
Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.
干预措施: Lens A (Device)
Lens B
daily disposable soft contact lens - control lens
Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.
干预措施: Lens B (Device)
结局指标
主要结局
Overall Ease of Lens Handling
时间窗: 1 week
Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)
次要结局
- Visual Acuity(1 week)
- Visual Acuity(Baseline - after lenses have settled for 10 minutes)