Changes of inflammatory cytokines and tear osmolarity in systemic sclerosis after treatment with liposomes sprayed

Abstract

AbstractPurpose To investigate the effect of treatment with a liposomal spray solution in patients with systemic sclerosis (SSc) and severe dry eye by measuring the levels of inflammatory cytokines and tear osmolarity.Methods Twenty‐two subjects (12M, 10F) aged 45.1+/‐7.1 years participated in this prospective, randomised, double‐masked investigation. DES was identified in patients with SSc according to the classification of Dry Eye Disease of International Dry Eye Workshop (2007) and tear osmolarity values (TearLab system) according to recommendations of the manufacturer with a cutoff value of 308 mOsm/L (3). Liposomal spray (nebulized, two sprays each, on the eyelids, 3 times per day for 3 weeks) with vitamin A and E was applied to one eye, and an equal volume of saline spray (control) applied to the contralateral eye. Non‐invasive tear film stability (NIBUT), osmolarity and inflammatory cytokines (IL‐1β, IL6, TNF‐α,IFN‐γ) were evaluated at baseline, and at 5, 10, 15 days after spray solution application.Results A highly significant reduction (p<0.01‐0.001) was detected in the inflammatory cytokine levels and osmolarity in tears of eye treated with the spray liposomes solution in comparison with fellow eye treated with sprayed saline solution. There were significant differences among the 2 eyes concerning tear osmolarity (p < 0.001) and TBUT (p < 0.05) scores.Conclusion This study showed the ability of liposomal spray application to modify the pro‐inflammatory cytokine profile and to increase stability characteristics of the pre‐ocular tear film in severe dry eye of SSc patients.This effect could be due to the anti‐inflammatory mechanism of the vitamins and also to the barrier effect of liposomes.