Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall Lens Fit Acceptance
研究概览
简要总结
The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each
详细描述
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- •Has an astigmatism of ≤ 1.00 D in subjective refraction;
- •Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
- •Demonstrates an acceptable fit with the study lenses;
- •Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection;
- •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 a study outcome variable;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Is an employee of the Centre for Ocular Research & Education;
- •Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
- •Has participated in any clinical trials within a week prior to the study.
研究组 & 干预措施
Test Contact lens
Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
干预措施: Test Contact Lens (Device)
Test Contact lens
Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.
干预措施: Control Contact Lens (Device)
Control Contact Lens
Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
干预措施: Test Contact Lens (Device)
Control Contact Lens
Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
干预措施: Control Contact Lens (Device)
结局指标
主要结局
Overall Lens Fit Acceptance
时间窗: 1 week
Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
次要结局
- Lens Centration(1 week)
- Post-blink Movement(1 week)
- Push-up Tightness(1 week)
- Lens Centration(Baseline)
- Post-blink Movement(Baseline)
- Push-up Tightness(Baseline)