In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel materials and that this protein remains largely active and promotes reduced cytokine response in an in vitro culture of human corneal epithelial cells. This study investigates whether these data transfer to the in vivo situation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
28
etafilcon A soft contact lens
nelfilcon A
University of Waterloo
Waterloo, Ontario, Canada
Total Protein and Total Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Time frame: 2 wks after baseline
Total Protein and Total Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Time frame: 6 wks after baseline
Total Protein and Lysosome Deposits
Measurement will be taken after the subject has worn the lenses for a full seven hours
Time frame: 12 wks after baseline
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.
Time frame: 2 wks after baseline
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Time frame: 6 wks after baseline
Quantity of Cytokines and Albumin in Tear Fluid
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Time frame: 12 wks after baseline
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