Vistakon Investigational Multi-purpose Contact Lens Care Solution.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 14
- 主要终点
- Slit Lamp Findings (SLF)
研究概览
简要总结
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •must be an adapted contact lens wearer
- •best corrected distance visual acuity must be 20/25 or better in each eye
- •must be wearing their habitual lenses on a daily wear basis
- •must be willing to refrain from swimming during the study
排除标准
- •any systemic diseases that may interfere with contact lens wear
- •any clinically significant ocular disease
- •any ocular infection
- •use of certain medications
- •any grade 2 or greater slit lamp findings
- •any know sensitivity to marketed contact lens care solutions
- •currently pregnant or lactating
- •monovision corrected
研究组 & 干预措施
Experimental Multi-Purpose Solution
contact lens care solution
干预措施: Vistakon Investigational Multi-Purpose Solution II (Device)
ReNu MultiPlus Multi-Purpose Solution
contact lens care solution
干预措施: ReNu MultiPlus Multi-Purpose Solution (Device)
结局指标
主要结局
Slit Lamp Findings (SLF)
时间窗: Up to 3 months Post Lens Wear
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Distance Visual Acuity (LogMAR)
时间窗: Up to 3 Months Post Lens Wear
Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.
次要结局
未报告次要终点