Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study

Conditions
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Myopia, Refractive Error

Intervention / Treatment
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* Drug: ReNu MultiPlus® MultiPurpose Solution
* Drug: OPTI-FREE® RepleniSH®
* Drug: Clear Care®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OPTI-FREE® RepleniSH®<br>33 participants will be assigned to use this lens care regimen during the six-week assessment period | Drug: OPTI-FREE® RepleniSH®<br>* Contact Lens care regimen<br>|
| Active Comparator: Clear Care®<br>33 participants will be assigned to use this lens care regimen during the six-week assessment period | Drug: Clear Care®<br>* Contact lens care regimen<br>|
| Active Comparator: ReNu MultiPlus® MultiPurpose Solution<br>33 participants will be assigned to use this lens care regimen during the six-week assessment period | Drug: ReNu MultiPlus® MultiPurpose Solution<br>* Contact lens care regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens, Lens care