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Doreen Schmidl, Katarzyna J Napora, René M Werkmeister, Peter Rosner, Gerhard Garhofer, Leopold Schmetterer; Effect of Lachrymal Substitutes on Tear Film Thickness in Patients with Moderate Dry Eye Syndrome. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3670.
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The aim of the present study was to test the effect of a single administration of three different lachrymal substitutes on tear film thickness in patients with moderate dry eye syndrome (DES).
The study was carried out in a randomized, double-masked, active-controlled design. 60 patients with moderate DES were included and randomized to receive either eye drops containing unpreserved trehalose combined with sodium hyaluronate, eye drops containing unpreserved sodium hyaluronate or sodium chloride eye drops. Tear film thickness (TFT) was measured using an ultrahigh-resolution optical coherence tomography (OCT) system. Measurements were performed pre-instillation and 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after administration of the medical products. In addition, break up time (BUT), Schirmer I test and subjective parameters were assessed.
Administration of lubricants significantly increased TFT in the group that had received trehalose combined with sodium hyaluronate (p<0.01) and in the group that had received sodium hyaluronate eye drops alone (p<0.01), whereas no significant change was observed after administration of sodium chloride (p=0.76). The increase in TFT caused by the combination product lasted significantly longer than with the formulation containing sodium hyaluronate alone (p<0.01). The highest TFT values were reached 10 minutes after drop administration in both groups where the increase has been found to be significant. No difference in BUT or Schirmer I test results was observed between the three treatments (p=0.66 and p=0.81, respectively) in the selected group of patients.
In conclusion, single instillation of trehalose combined with sodium hyaluronate and sodium hyaluronate eye drops leads to an increase in tear film thickness, whereas no difference was observed for sodium chloride. Whether this is related to the difference in viscosity, different mucin adhesion or other factors needs to be further investigated.
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