NCT01898260已完成不适用
Multi-Center Clinical Evaluation of Two Daily Disposable Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Initial Comfort
研究概览
简要总结
The purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adapted soft contact lens wearer;
- •Spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive);
- •Spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other;
- •Correctable to 6/9 (20/30) in both eyes;
- •Read, understood and signed the informed consent;
- •Willing to comply with the wear schedule;
- •Willing to comply with the study visit schedule;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any active corneal infection, injury or inflammation;
- •Systemic or ocular allergies which might interfere with contact lens wear;
- •Systemic or ocular disease which might interfere with contact lens wear;
- •Strabismus or amblyopia;
- •Corneal refractive surgery and any anterior segment surgery;
- •Use of systemic/topical medication contraindicating contact lens wear;
- •Use of gas permeable contact lenses within 1 month preceding the study;
- •Participation in any concurrent clinical trial or in the last 30 days;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Initial Comfort
时间窗: Baseline
Initial Comfort will be assessed bilaterally by the participant at time of dispense. Initial Comfort will be graded on a 1-10 scale (10=cannot be felt, 1=painful).
次要结局
- End of Day Comfort(Day 7)
- Overall Comfort(Day 7)
- Overall Handling at Time of Removal(Day 7)
研究者
研究点 (1)
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