Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses (BEAGLE 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Lens Handling for Lens Insertion
研究概览
简要总结
The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.
详细描述
The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (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
- •Subjects will only be eligible for the study if:
- •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 silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- •Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
- •Demonstrates an acceptable fit with the study lenses;
- •Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.
排除标准
- •Subjects will not be eligible to take part in the study if:
- •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 (verbal confirmation at the screening visit);
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Is an employee of the Centre for Ocular Research & Education;
- •Has participated in the BEAGLE (EX-MKTG-104) study.
研究组 & 干预措施
somofilcon A
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.
干预措施: somofilcon A (Device)
etafilcon A
Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
干预措施: etafilcon A (Device)
结局指标
主要结局
Lens Handling for Lens Insertion
时间窗: 1 Week
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
时间窗: 1 week
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
时间窗: Day 1
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
时间窗: Day 3
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Insertion
时间窗: Day 5
Lens handling for lens insertion (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
时间窗: Day 1
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
时间窗: Day 3
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
Lens Handling for Lens Removal
时间窗: Day 5
Lens handling for lens removal (subjective rating; 0 - 10 integer scale, 0 - very difficult, 10 - very easy)
次要结局
- Post-blink Movement(1 -week)
- Lens Centration(1 week)
- Push-up Tightness(1 week)
- Lens Centration(Baseline (after 10 minutes of lens fitting))
- Post-blink Movement(Baseline (after 10 minutes of lens fitting))
- Push-up Tightness(Baseline (after 10 minutes of lens fitting))