NCT01342107已完成不适用
The Effect of Alcon Multi-Purpose Disinfecting Solution (MPDS) on Lens Wettability
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Lens Wettability
研究概览
简要总结
The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •18 years or age or older with normal eyes, other than correction for refractive error.
- •At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
- •Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
- •Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
- •Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
- •Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
- •Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit
- •Use of lens rewetting drops is acceptable.
- •History or current ocular infections or ocular inflammatory events.
- •Ocular surgery within the past year.
- •Participation in any investigational study within the past 30 days.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Lens Wettability
时间窗: 16 hours
As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.
次要结局
未报告次要终点
研究者
研究点 (2)
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