A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Slit Lamp Findings > Grade 2
研究概览
简要总结
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
- •Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
- •Subjects must be free of any anterior segment disorders.
- •Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.
排除标准
- •Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
- •Subjects who are allergic to any component in the study care products.
研究组 & 干预措施
Test lens
Test contact lens will be worn on a daily disposable wear basis.
干预措施: Test, daily disposable contact lens (Device)
SofLens lens
The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
干预措施: SofLens daily disposable contact lens (Device)
结局指标
主要结局
Slit Lamp Findings > Grade 2
时间窗: 4 visits over 3 months
Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses
High Contrast, Distance logMAR Visual Acuity (VA)
时间窗: 4 visits over 3 months
Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint
次要结局
未报告次要终点