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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-07-31

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.

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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.

Conditions

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Myopia Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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OPTI-FREE® RepleniSH®

33 participants will be assigned to use this lens care regimen during the six-week assessment period

Group Type ACTIVE_COMPARATOR

OPTI-FREE® RepleniSH®

Intervention Type DRUG

Contact Lens care regimen

Clear Care®

33 participants will be assigned to use this lens care regimen during the six-week assessment period

Group Type ACTIVE_COMPARATOR

Clear Care®

Intervention Type DRUG

Contact lens care regimen

ReNu MultiPlus® MultiPurpose Solution

33 participants will be assigned to use this lens care regimen during the six-week assessment period

Group Type ACTIVE_COMPARATOR

ReNu MultiPlus® MultiPurpose Solution

Intervention Type DRUG

Contact lens care regimen

Interventions

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ReNu MultiPlus® MultiPurpose Solution

Contact lens care regimen

Intervention Type DRUG

OPTI-FREE® RepleniSH®

Contact Lens care regimen

Intervention Type DRUG

Clear Care®

Contact lens care regimen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be 18 years of age and may be of any race and either gender.
2. Subjects must not have ever worn contact lenses.
3. Subjects must have normal, healthy eyes.

Exclusion Criteria

1. Subjects must not use additional lens cleaners.
2. subjects must not have any ocular or systemic disease.
3. Subjects must not have history of ocular surgery/trauma within the last 6 months.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes