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Emilio C Campos, Piera Versura, Giuseppe Giannaccare, Michela Fresina, Chiara Fariselli; Trehalose/Hyaluronate eyedrops effects on ocular surface parameters, inflammatory markers and mucin expression in evaporative Dry Eye patients. Invest. Ophthalmol. Vis. Sci. 2017;58(8):499.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the levels of ocular surface functional parameters, inflammatory markers in tears and mucin expression in conjunctival epithelium before and after topical treatment with Trehalose/Hyaluronate based tear substitute (Thealoz® Duo, laboratoires Théa, France) in dry eye (DE) patients
Fifteen evaporative DE patients (fourteen women aged 54 yrs as a median, one man aged 58 yrs, DEWS severity level 2-3) were evaluated in an open label, not comparative, pilot study at enrollment (V0), after 2 days of washout (baseline, V1), and after 1 month (V2) and 2 months (V3, endpoint) of treatment with Thealoz® Duo (one drop/eye/4 times daily). Data for ocular subjective symptoms of discomfort (OSDI and VAS pain score), tear film (Schirmer test I, TFBUT), ocular surface damage (corneal NEI and conjunctival van Bijsterveld scores, impression cytology scored by Nelson’s grade and goblet cells (GC) number/mm2 analysis, and MUC4 immuno-staining evaluated by H-score) and inflammation (IL-1β, IL-6 and IL-8 levels) were measured. The association among different variables were also calculated
Parameters showing significant (always p<0.01) changes at endpoint as compared to baseline were: OSDI score (respectively mean±SD, 22.2±2.9 vs 38.7±12.7), VAS score (3.4±1.3 vs 6.6±1.4), TFBUT (7.5±1.9 vs 5.4±2.3 sec), corneal staining (NEI grade 1.23±0.64 vs 3.37±0.49), conjunctival staining (1.73±0.64 vs 4.17±0.91), impression cytology (Nelson grade 1.10±0.20 vs 1.63±0.54), GC density (139.9±22.0 vs 107.8±16.2 GC/mm2). IL-1b, IL-6 and IL-8 tear levels were found above the minimum detectable level in all subjects at baseline (respectively mean±SD, pg/ml tears: 33.6±17.3, 112.0±24.3 and 1139.2±671.7) with a significant decrease at endpoint (12.3±6.9, 26.6±25.2 and 743.5±477.7), p<0.01. Cytokine levels were correlated to surface damage at baseline (Pearson’s r ranging 0.45-0.59, p<0.0001) but not at endpoint
A decrease in ocular discomfort symptoms, surface damage and tear cytokine levels was shown after two month treatment with Thealoz® Duo eyedrops in DE patients, along with a significant GC density recovery. These results may be associated to the synergic action of both trehalose and hyaluronic acid in targeting different entries of the DE vicious loop
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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