Study of A New Contact Lens Cleaning and Disinfecting Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 2
- 主要终点
- Percentage of Eyes With > Grade 2 Slit Lamp Findings
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Subjects must be habitual wearers of one of the protocol specified lenses.
- •Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
- •Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- •Subjects must agree to wear their lenses on a daily wear basis for approximately three months.
排除标准
- •Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
- •Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
- •Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •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 with any scar or neovascularization within the central 4 mm of the cornea.
- •Subjects who are allergic to any component in the study care products.
结局指标
主要结局
Percentage of Eyes With > Grade 2 Slit Lamp Findings
时间窗: 3 months
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.
次要结局
未报告次要终点