Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses: Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Overall subjective comfort
研究概览
简要总结
The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.
详细描述
This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.
The primary outcome variable for this study is overall subjective comfort.
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
- Single (Investigator)
盲法说明
Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently wearing hydrogel, spherical DD contact lenses at least 5 days/week
- •Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
- •No ocular or systemic disease that contra-indicates soft contact lens wear
排除标准
- •Currently wearing silicone hydrogel DD contact lenses
- •Currently wearing 1-DAY ACUVUE® MOIST (comparator) contact lenses
- •Currently using rewetting drops with habitual contact lenses
- •Vision not correctable to 20/30
- •Participating in another clinical trial
结局指标
主要结局
Overall subjective comfort
时间窗: 2 weeks after contact lens wear
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
次要结局
- End of day subjective comfort(Visit 2 and 3 - Approximately 1 and 2 weeks, respectively)
- Overall subjective lens preference(Visit 3 - After approximately 2 weeks of contact lens wear)
- Subjective vision(Visit 2 and 3 - Approximately 1 and 2 weeks, respectively)