Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Handling
研究概览
简要总结
The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.
详细描述
The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 16 and 45 years of age (inclusive)
- •Adapted soft contact lens (CL) wearers (i.e. > 1 month)
- •Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
- •Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
- •Correctable to 6/9 (20/30) in both eyes
- •Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
- •Have read, understood and signed the informed consent
- •Willing to comply with the wear schedule (at least 40 hours per week)
- •Willing to comply with the study visit schedule
排除标准
- •Any active corneal infection, injury or inflammation
- •Systemic or ocular allergies, which might interfere with CL wear
- •Systemic disease, which might interfere with CL wear
- •Ocular disease, which might interfere with CL wear
- •Strabismus, amblyopia
- •Subjects who have undergone corneal refractive surgery and any anterior segment surgery
- •Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
- •Pregnant or lactating
- •Use of systemic/topical medication contraindicating CL wear
- •Use of gas permeable contact lenses within the last month
- •Employees of the investigational site or immediate family members of Investigators
- •Participation in any concurrent clinical trial or in the last 30 days
研究组 & 干预措施
stenfilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
干预措施: etafilcon A (Device)
etafilcon A
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
干预措施: stenfilcon A (Device)
结局指标
主要结局
Handling
时间窗: two weeks and four weeks from baseline visit
Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).
Satisfaction With Handling
时间窗: two weeks and four weeks from baseline visit
Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
次要结局
- Comfort(two weeks and four weeks from baseline visit)
- Dryness(two weeks and four weeks from baseline visit)
- Satisfaction With Dryness(two weeks and four weeks from baseline visit)
- Satisfaction With Comfort(two weeks and four weeks from baseline visit)