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
- 312
- 试验地点
- 15
- 主要终点
- Slit Lamp Findings
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
Multi-purpose contact lens care solution.
干预措施: Vistakon Investigational Multi-Purpose Solution I (Device)
ReNu MultiPlus Multi-Purpose Solution
Multi-purpose 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
时间窗: 3 months
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.
Distance Visual Acuity (LogMAR)
时间窗: Up to 3 Months
Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.
次要结局
未报告次要终点