Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
Overview
- Phase
- Phase 4
- Intervention
- OPTI-FREE® RepleniSH®
- Conditions
- Myopia
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Enrollment
- 94
- Locations
- 2
- Primary Endpoint
- Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
OPTI-FREE® RepleniSH®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Intervention: OPTI-FREE® RepleniSH®
Clear Care®
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Intervention: Clear Care®
ReNu MultiPlus® MultiPurpose Solution
33 participants will be assigned to use this lens care regimen during the six-week assessment period
Intervention: ReNu MultiPlus® MultiPurpose Solution
Outcomes
Primary Outcomes
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events(Six weeks)