Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
This trial is active, not recruiting.
|Conditions||myopia, refractive error|
|Treatments||renu multiplus® multipurpose solution, opti-free® replenish®, clear care®|
|Sponsor||Massachusetts Eye and Ear Infirmary|
|Collaborator||University of Iowa|
|Start date||August 2010|
|End date||September 2012|
|Trial size||100 participants|
|Trial identifier||NCT01250925, 10-04-029|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
|Primary purpose||supportive care|
Corneal Epithelial Immune Status
time frame: Six weeks
time frame: Six weeks
Male or female participants at least 18 years old.
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.
|Official title||Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study|
|Principal investigator||Pedram Hamrah, MD|
|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.|
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