May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
A Pilot Study of the Effect of Silicone-Hydrogel Lenses and Marketed Multipurpose Solutions on Human Epithelial Barrier Function
Author Affiliations & Notes
  • J. Q. Hall, Jr.
    Southern California College of Optometry, Fullerton, California
  • J. R. Paugh
    Southern California College of Optometry, Fullerton, California
  • M. C. Peinovich
    Southern California College of Optometry, Fullerton, California
  • A. C. Ramsey
    Alcon Research, Ltd., Fort Worth, Texas
  • D. Meadows
    Alcon Research, Ltd., Fort Worth, Texas
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 5400. doi:
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      J. Q. Hall, Jr., J. R. Paugh, M. C. Peinovich, A. C. Ramsey, D. Meadows; A Pilot Study of the Effect of Silicone-Hydrogel Lenses and Marketed Multipurpose Solutions on Human Epithelial Barrier Function. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5400.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose:: There is increasing evidence that certain contact lens material-solution combinations induce clinically meaningful corneal compromise. This was a pilot investigation, using barrier function determination as a sensitive measure of corneal compromise, to objectively quantitate these lens-solution bio-incompatibilities.

Methods:: Six young, adapted hydrogel daily lens wearers were recruited for this randomized study. New silicone hydrogel lenses (balafilcon A and lotrafilcon B) were soaked in pre-conditioned lens cases in 1) a polyquaternium-1-based solution, 2) a PHMB-based solution, or 3) non-preserved saline, which served as the contralateral control. Lenses in the multipurpose solutions were soaked 6-8 hours (test condition) and control lenses were soaked for 2 hours (active control). At 2 hours of wear epithelial barrier function was determined using the single drop method and a scanning fluorometer. The fluorescein penetration rate, Pdc, in nm/sec was calculated. The ratio of the test solution Pdc to the control solution Pdc served as the principal outcome measure.

Results:: The Pdc ratios ranged from slightly less than 1.0 (parity; both solutions) to as much as 286 (only for the PHMB-based solution), indicating an enormous range in dye penetration rate. The greater ratios mirrored the corneal staining scores on a 0-4 clinical scale. For example, the balafilcon A - PHMB-based combination produced a Pdc ratio of 286 and demonstrated grade 4 staining in the test eye vs. grade 1.5 for the control. Pdc ratios for the three lens-solution combinations averaged 65.79, 2.31 and 1.0 for the balafilcon A-PHMB, lotrafilcon B-PHMB and lotrafilcon B-polyquaternium-1 lens-solution combinations, respectively.

Conclusions:: The single-drop barrier method appears useful in providing sensitive, objective evidence of corneal compromise. These pilot data suggest that very large differences in lens-solution toxicities can exist and further work is required with additional lens-solution combinations to precisely establish the statistical and clinical differences.

Clinical Trial:: www.clinicaltrials.gov NCT00407238

Keywords: contact lens • cornea: clinical science • ocular irritancy/toxicity testing 
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