Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tear Protein Expression
研究概览
简要总结
The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For non-lens wearers:
- •Normal eyes.
- •Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
- •Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
- •Other protocol-defined inclusion criteria may apply.
- •For contact lens wearers:
- •Currently wearing soft contact lenses.
- •Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
- •Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
- •Reports only occasional use of contact lens rewetting drops or artificial tears.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •For non-lens wearers and contact lens wearers:
- •Pregnant.
- •Participating in another research study.
- •Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Contact lens wearers
Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.
干预措施: Opti-Free RepleniSH (Device)
Contact lens wearers
Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.
干预措施: ReNu MultiPlus (Device)
Contact lens wearers
Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.
干预措施: Balafilcon A (Device)
Contact lens wearers
Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.
干预措施: Unisol 4 (Other)
Non-lens wearers
Non-lens wearers completed one study visit and served as the control group.
结局指标
主要结局
Tear Protein Expression
时间窗: 1 day
次要结局
- Corneal Staining(1 day)