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The purpose of this study is to assess corneal staining and to measure the relative corneal epithelial "barrier" function (the degree to which the cornea can prevent penetration of colored sodium fluorescein dye into the eye) after 8 hours of wear with a known soft contact lens and multipurpose lens care solution combination.
This investigation will evaluate corneal staining and epithelial barrier function after eight hours of contact lens wear, which is past the peak staining time and more typical of daily lens wear time. A silicone hydrogel lens and multipurpose solution combination shown to induce significant corneal staining ( e.g. equivalent Grade 3 out of Grade 4 scale) will be used to evaluate potential corneal compromise. The study will be a prospective, single-center, double-masked, contralateral, daily wear investigation in adapted soft contact lens wearers. After a three day washout period (without lens wear, lenses will then be worn on one day for eight hours. Corneal staining and barrier function will be determined for a regimen and a saline control situation for each subject. Staining will be graded using the Efron Grading Scale, and permeability data will be estimated as the fluorescein penetration rate, Pdc in nm/sec for the test and control condition.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Southern California Colege of Optometry
Fullerton, California, United States
Start Date
October 1, 2009
Primary Completion Date
January 1, 2010
Completion Date
January 1, 2010
Last Updated
September 18, 2020
30
ACTUAL participants
ReNu Multiplus multipurpose disinfecting solution
DEVICE
Control
DEVICE
Lead Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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