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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
94
University of Iowa
Iowa City, Iowa, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)
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.
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Time frame: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)
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.
Time frame: Six weeks
Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)
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.
Time frame: Six weeks
Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events
The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.
Time frame: Six weeks