NCT01164865已完成不适用
The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Change From Baseline in Ocular Comfort Rating at 2 Weeks
研究概览
简要总结
The purpose of this study was to assess comfort in soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wear silicone hydrogel contact lenses on a daily wear basis;
- •Currently using OPTI-FREE RepleniSH contact lens solution;
- •Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
- •Read, sign, and date IRB-approved informed consent and the privacy document;
- •Be generally healthy and have normal ocular health;
- •Be be willing to follow the study procedures and visit schedule;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Use of additional lens cleaners;
- •Known sensitivity to any ingredient in either of the test articles;
- •Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
- •Prior (within 7 days of enrollment) or current ocular infections;
- •Clinically significant lash or lid abnormality;
- •History of ocular surgery/trauma within the last 6 months;
- •Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
- •Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change From Baseline in Ocular Comfort Rating at 2 Weeks
时间窗: Baseline (Day 0), 2 weeks
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described "how your eyes feel right now."
Likert Questionnaire Scores at 2 Weeks
时间窗: 2 weeks
The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.
次要结局
未报告次要终点
研究者
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