A 30 Day, Multi-Centered, Open Label Study To Determine Comfort and Overall Contact Lens Wearing Experience Using OPTI-FREE RepleniSH® MPDS as Compared to COMPLETE®MPS Easy Rub™ or ReNu MultiPlus® in Daily Wear Soft Contact Lens Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Comfort Ratings at 30 Days
研究概览
简要总结
The purpose of this study was to demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be between 18 and 65 years of age.
- •Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.
- •Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.
- •Must be using either COMPLETE Multi-Purpose Solution (MPS) Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment.
- •Must be free of any contact lens-related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of end-of-day dryness not limiting all day wear.
- •Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
- •Must be willing to maintain pre-enrollment systemic medication regimens during the study.
- •Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Has used any topical medication or rewetting drops for 7 days prior to enrollment.
- •Achieves best visual correction by monovision.
- •Has modified their systemic medications within 30 days prior to enrollment.
- •Has switched brands of cosmetics during the 30 days prior to the study.
- •Has a history of allergy to any study product ingredients.
- •Is unwilling or unable to meet the study visit timeline.
- •Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Comfort Ratings at 30 Days
时间窗: 30 days
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.
Comfort Ratings at Baseline
时间窗: Baseline (Day 0)
Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.
次要结局
未报告次要终点