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

Mass Eye and Ear

Status and phase: Completed; Phase 4

Conditions: Myopia; Refractive Error

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01250925

10-04-029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 3 patient groups

OPTI-FREE® RepleniSH®

Active Comparator group

Description:

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

Treatment:

Drug: OPTI-FREE® RepleniSH®

Clear Care®

Active Comparator group

Description:

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

Treatment:

Drug: Clear Care®

ReNu MultiPlus® MultiPurpose Solution

Active Comparator group

Description:

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

Treatment:

Drug: ReNu MultiPlus® MultiPurpose Solution