Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
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
- Lens Tightness on Push-up
研究概览
简要总结
The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.
详细描述
This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
enfilcon A (habitual)
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test)
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
干预措施: fanfilcon A (test) (Device)
结局指标
主要结局
Lens Tightness on Push-up
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Lens Fit - Centration
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Lens Fit - Post-blink Movement
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Overall Fit Acceptance
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.
次要结局
- Overall Vision Satisfaction(Baseline, 1 week, 2 weeks, and 4 weeks)
- Dryness Overall(Baseline, 1 week, 2 weeks, and 4 weeks)
- Overall Satisfaction(Baseline, 1 week, 2 weeks, and 4 weeks)
- Wearing Times(Baseline, 1 week, 2 weeks, and 4 weeks)
- Conjunctival Staining(Baseline, 1 week, 2 weeks, and 4 weeks)
- Handling(Baseline, 1 week, 2 weeks, and 4 weeks)
- Lens Preference Overall(1 week, 2 weeks, and 4 weeks)
- Overall Comfort(Baseline, 1 week, 2 weeks, and 4 weeks)
- Corneal Staining(Baseline, 1 week, 2 weeks, and 4 weeks)