Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
研究概览
简要总结
The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •18 years or older
- •Soft contact lens wear on a daily wear basis
- •Able to wear contact lenses for at least 8 hours
- •Generally healthy and have normal ocular health
- •Other protocol-defined inclusion criteria may apply
排除标准
- •No use of additional lens cleaners
- •No known sensitivities to any ingredient in the test article
- •No history of ocular surgery/trauma within the last six months
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
OPTI-FREE
OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen
干预措施: OPTI-FREE PureMoist (Device)
结局指标
主要结局
Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30
时间窗: Baseline (Day 0), Day 30
Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.
Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30
时间窗: Baseline (Day 0), Day 30
Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (\>/= 1 mm). The five regions were summed, for a summed total range of 0-20.
次要结局
未报告次要终点