A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Symptoms and Complaints
研究概览
简要总结
Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater
- •Visual acuity (VA) correctable to 0.3 logMar or better (driving vision)
- •Clear central cornea
排除标准
- •Systemic disease affecting ocular health
- •Using systemic or topical medications
- •Wears monovision or multifocal contact lenses
- •Any grade 2 or greater slit lamp findings
- •Adapted wearer of Ciba Focus Dailies Toric lens upon study entry
研究组 & 干预措施
SofLens DD Toric
Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
干预措施: SofLens DD Toric (Device)
Ciba Vision Toric Lens
Ciba Vision Focus Dailies Toric Contact Lens
干预措施: Ciba Vision Focus Dailies Toric Contact Lens (Device)
结局指标
主要结局
Symptoms and Complaints
时间窗: Over-all follow-up visits for 2 week period
1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Contact Lens High Contrast Visual Acuity
时间窗: Over-all follow-up visits, 2 weeks
VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.
次要结局
- Slit Lamp Findings(Over-all follow-up visits, 2 weeks)