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

Phase 4

Completed

Conditions: Myopia
Refractive Error

Interventions: Drug: OPTI-FREE® RepleniSH®
Drug: Clear Care®
Drug: ReNu MultiPlus® MultiPurpose Solution

Registration Number: NCT01250925

Lead Sponsor: Massachusetts Eye and Ear Infirmary

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 94

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTI-FREE® RepleniSH®	OPTI-FREE® RepleniSH®	33 participants will be assigned to use this lens care regimen during the six-week assessment period
Clear Care®	Clear Care®	33 participants will be assigned to use this lens care regimen during the six-week assessment period
ReNu MultiPlus® MultiPurpose Solution	ReNu MultiPlus® MultiPurpose Solution	33 participants will be assigned to use this lens care regimen during the six-week assessment period

Primary Outcome Measures

Name	Time	Method
Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events	Six weeks	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.