A Study to Evaluate the Product Performance of a Modified Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Percentage of Eyes With > Grade 2 Slit Lamp Findings
研究概览
简要总结
This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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 free of any anterior segment disorders.
- •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 be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
- •Subjects must be habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses.
- •Subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study.
- •Subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment.
- •Subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog).
- •Subjects must feel that being in an urban environment has a negative effect on their lens wearing experience.
- •Subjects must have access to an internet connection and be able to send and receive email.
排除标准
- •Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or 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 an active ocular disease or who are using any ocular medication.
- •Subjects with any grade 2 or greater finding during the slit lamp examination
- •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 with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- •Subjects who are allergic to any component in the study care products.
研究组 & 干预措施
SofLens in investigational solution
Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.
干预措施: SofLens in investigational solution (Device)
SofLens in currently marketed solution
SofLens daily disposable contact lens packaged in currently marketed storage solution.
干预措施: SofLens in currently marketed solution (Device)
结局指标
主要结局
Percentage of Eyes With > Grade 2 Slit Lamp Findings
时间窗: At 2 weeks follow up
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.
Visual Acuity
时间窗: At 2 weeks follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
次要结局
- Symptoms and Complaints(At 2 weeks follow up)