Safety and Performance of an Artificial Tear Containing Arabinogalactan, Trehalose and Hyaluronic Acid in the Treatment of Dry Eye in Subjects with Signs of Inflammation of the Ocular Surface

Background: In this study it has been evaluated the safety and the clinical performance of a new combination of topical solution based on arabinogalactan, trehalose and hyaluronic acid, in reducing symptoms and signs of inflammation in a selected population affected by dry eye disease. Methods: The study enrolled 25 patients (ranging from 57 to 71 years) with signs and symptoms of dry eye disease. They received a combination therapy with arabinogalactan, trehalose and hyaluronic acid one drop three times a day for the first week and subsequently according to their symptoms. Ocular surface disease index score, tolerability and adherence were used to evaluate subjective symptoms of dry eye disease at enrolment (T0), week 1 (T1) and week 4 (T2). Clinical signs were assessed at T0 and T2. The assessment plan included: slit-lamp examination of the anterior segment, uncorrected and corrected visual acuity, ocular protection index, tear film break up time, osmolarity, meniscometry, evaluation of conjunctival hyperemia according to Efron’s classification, the presence of MMP-9, conjunctival and corneal staining and intraocular pressure. Results: The study group showed significant improvement in several clinical parameters after treatment. Ocular surface disease index score was significantly lower at the end of the follow up period, also evaluation of tolerability (ocular burning, ocular itching and blurred vision), before and after instillation, showed a statistically significant improvement at T0 and T1. Improvements in tear film break up time, meniscometry results and conjunctival and corneal hyperemia were statistically significant in the study group (p <0.05). A statistically significant, decrease in MMP-9 levels was also observed. Conclusions: Preliminary findings suggest that the new combination of topical solution based on arabinogalactan, trehalose and hyaluronic acid, could be effective in reducing early inflammatory markers, symptoms and signs, associated with the progression of dry eye disease.