Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Comfort
研究概览
简要总结
The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration
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
- Single (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
- •Subject is a habitual wearer of planned replacement soft contact lenses
- •VA correctable to 0.3 LogMar or better (driving vision)
- •Clear central cornea
- •Subject uses a lens care system on a regular basis
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
结局指标
主要结局
Comfort
时间窗: Over-all follow-up visits from baseline to 1 month
Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.
Slit Lamp Findings
时间窗: Over-all follow-up visits from baseline to1 month
Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.
Lens Deposits
时间窗: Over-all study visits, baseline to 1-month
Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.
次要结局
未报告次要终点