Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
研究概览
简要总结
The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.
详细描述
An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- 是
入选标准
- •Subjects must be 18 years of age and may be of any race and either gender.
- •Subjects must not have ever worn contact lenses.
- •Subjects must have normal, healthy eyes.
排除标准
- •Subjects must not use additional lens cleaners.
- •subjects must not have any ocular or systemic disease.
- •Subjects must not have history of ocular surgery/trauma within the last 6 months.
研究组 & 干预措施
OPTI-FREE® RepleniSH®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
干预措施: OPTI-FREE® RepleniSH® (Drug)
Clear Care®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
干预措施: Clear Care® (Drug)
ReNu MultiPlus® MultiPurpose Solution
33 participants will be assigned to use this lens care regimen during the six-week assessment period
干预措施: ReNu MultiPlus® MultiPurpose Solution (Drug)
结局指标
主要结局
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)
时间窗: Six weeks
The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.
次要结局
- Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events(Six weeks)