Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Average Corneal Staining Area
研究概览
简要总结
The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.
详细描述
Corneal staining and subjective responses for ocular redness and comfort will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •18 years of age or older.
- •Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
- •Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History of hypersensitivity to any components of the multi-purpose solution.
- •Evidence or history of ocular conditions as prescribed in protocol.
- •One functional eye or a monofit lens
- •Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
- •Significant corneal staining at visit 1 of each study period as prescribed in protocol.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Average Corneal Staining Area
时间窗: After 2 hours of wear
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 fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.
Total Corneal Staining Type
时间窗: After 2 hours of wear
Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (\>/= 1mm). The five regions were summed.
次要结局
- Ocular Comfort(After 2 hours of wear)
- Ocular Redness(After two hours of wear)