A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Antimicrobial Efficacy
研究概览
简要总结
This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
- •Must be able and willing to comply with all treatment and follow-up study procedures.
- •Must have a clear central cornea.
- •VA correctable to 0.3 LogMar or better (driving vision)
排除标准
- •Systemic disease affecting ocular health.
- •Using systemic or topical medications.
- •Wear monovision, multifocal or toric contact lenses.
- •Any grade 2 or greater slit lamp findings.
- •Pregnancy
结局指标
主要结局
Antimicrobial Efficacy
时间窗: 2 weeks, 3 months
Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora \<103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
次要结局
- Solution Related AE's and Lens Changes(3 months, 6 months)
- Solution Utlility(3 months, 6 months)