NCT04492397已完成不适用
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 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.
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
- Post-blink Movement(1 week)
- Push-up Tightness(1 week)
- Lens Centration(1 week)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens WearersMyopiaNCT01134211CIBA VISION316
已完成
不适用
Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens WearersMyopiaNCT04668989Coopervision, Inc.68
已完成
不适用
Performance Evaluation of Different Daily Disposable Multifocal Contact LensesPresbyopiaNCT05763628Coopervision, Inc.59
已完成
不适用
Performance Assessment of a Modified Daily Disposable Contact LensRefractive ErrorsMyopiaHyperopiaNCT03762668Alcon Research62
已完成
不适用
Comparing the Performance of 1 Day Multifocal Contact LensesPresbyopiaNCT04449263Coopervision, Inc.60