Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- Comfort
研究概览
简要总结
The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.
详细描述
This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comfort
时间窗: Baseline, 2 weeks, 4 weeks
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
次要结局
- Wearing Times(Baseline, 2 weeks, 4 weeks)
- Biomicroscopy Scores(Baseline, 2 weeks, 4 weeks)
- Deterioration in Comfort(Baseline, 2 weeks, 4 weeks)
- Overall Lens Handling(Baseline, 2 weeks, 4 weeks)
- Film Deposits(2 weeks and 4 weeks)
- Comfortable Wearing Time Via SMS (Short Message Service)(Days 3, 12, 26)
- Vision Quality(Baseline, 2 weeks, 4 weeks)
- Visual Acuity (VA)(Baseline, 2 weeks, 4 weeks)
- Lens Centration(Baseline, 2 weeks, 4 weeks)
- Corneal Coverage(Baseline Visit, 2 weeks follow-up, 4-weeks follow-up)
- Post-Blink Movement(Baseline, 2 weeks, 4 weeks)
- Lens Tightness Push-up(Baseline, 2 weeks, 4 weeks)
- Dryness(Baseline, 2 weeks, 4 weeks)
- Lens Surface Wetting(Baseline, 2 weeks, 4 weeks)
- White Spot Deposits(2 weeks and 4 weeks)
- Primary Gaze Lag(Baseline, 2 weeks, and 4 weeks)
- Overall Fit Acceptance(Baseline, 2 weeks, 4 weeks)