Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 541
- 试验地点
- 1
- 主要终点
- Contact Lens Deposits
研究概览
简要总结
To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution
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
- •subject is a habitual wearer of a silicone hydrogel or group IV contact lens
- •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
研究组 & 干预措施
Ciba Vision Aquify Multipurpose Solution
Ciba Vision Aquify Multipurpose Solution for use with contact lens care
干预措施: Ciba Vision Aquify Multipurpose Solution (Device)
Multipurpose Solution - Rub Care
Bausch & Lomb Multipurpose Solution for use with contact lens care
干预措施: Bausch & Lomb Multipurpose Solution - Rub Care (Device)
Multipurpose Solution - No Rub Care
Bausch & Lomb Multipurpose Solution for use with contact lens care
干预措施: Bausch & Lomb Multipurpose Solution - No Rub Care (Device)
结局指标
主要结局
Contact Lens Deposits
时间窗: At each visit for 3 months
Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.
Slit-lamp Findings > Grade 2
时间窗: Over 4 visits for 3 month period
eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.
Subjective Responses to Comfort Related Symptoms/Complaints
时间窗: Over 4 visits for the 3 month period
Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
次要结局
未报告次要终点