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G. S. Raynor, A. T. Sheyman, S. P. Epstein, M. L. Massingale, P. G. Dentone, P. A. Asbell; Modulation of HLA-DR in Dry Eye Subjects Following 30 Days of Treatment With a Novel Artificial Tear Product. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6268.
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To correlate improvements in corneal health with HLA-DR, a specific biomarker of inflammation, following 30 continuous days of treatment with a novel over-the-counter (OTC) artificial tear product in subjects with Dry Eye.
This was a single arm, open label study with 20 patients with signs and symptoms of dry eye disease. The test solution was a polyethylene glycol (PEG) and propylene glycol (PG) based tear containing HP-Guar as a gelling agent. At baseline and after 30 continuous days of 4x/day use, the following measurements were conducted: DEWS dry eye categorization, OSDI, TFBUT, corneal and conjunctival staining, Schirmer’s 1, fluorophotometry and immunofluorescent histochemical staining followed by impression cytology with flow cytometric analysis of HLA-DR. Statistical evaluation of both parametric data was conducted using computer generated paired t-tests, correlation coefficients and an One Way Analysis of Variance with comparisons between the baseline and 30 days measurements, non-parametric data was evaluated with Paired t-Tests and the Spearman R correlation. Two-tailed significance was established at a confidence level of 0.05 ≥ P ≥ 0.95. The flow cytometric analysis was performed by an independent observer in a masked fashion to minimize bias.
Seventeen (17) patients completed the study with mean age = 61 yrs + 16, 12 female/5 male. DEWS [(pretreatment baseline) Day "0": 2.10 + 0.90, Day 30: 0.82 + 0.83; Paired t-Test p ≤ 0.0001], OSDI (Day "0": 41.54 + 23.62, Day 30: 32.91 + 23.16; p = 0.02), corneal staining (Day "0": 5.38 + 3.63, Day 30: 2.71 + 3.08; p ≤ 0.0001), TFBUT [Day "0": 2.39 + 1.64, Day 30: 4.19 + 2.25 (seconds); p ≤ 0.0001), HLA-DR+ [(histogram gate/region)Day "0": 6.81 + 6.24/20.67 + 12.91, Day 30: 3.77 + 2.12/2.06 + 1.69; p = 0.02/p ≤ 0.0001] were all statistically significantly different following 30 days of treatment.
Following 30 continuous days of use with the PEG/PG product, there were statistical improvements in measurements of general ocular health and a corresponding statistical reduction in the level of HLA DR. This is the first reported evidence that an OTC artificial tear can stabilize/normalize the ocular surface allowing reduction in a biomarker of ocular inflammation.
Clinical Trial: :
Mount Sinai School of Medicine - NCT00946777
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