Randomized controlled trial of trehalose: An efficient autophagic bioprotectant in the management of dry eye disease

PURPOSE: To compare the therapeutic effect of sodium hyaluronate (SH)-trehalose (Trehalube, Microlabs, Bangalore, India, SH 0.1% and trehalose 3%) or SH (0.1% Hylotears, Raymed, Chandigarh, India) alone in patients with dry eye disease (DED). MATERIALS AND METHODS: Patients were randomized into two groups: SH-trehalose (SH 0.1% and trehalose 3%) or SH (0.1% Hylotears) alone. The Ocular Surface Disease Index (OSDI) questionnaire was used to assess patient's symptoms. Patients were followed up at 4 and 8 weeks, and OSDI score, tear film break-up time (TBUT), tear film height (TFH), Schirmer's test, and conjunctival staining were evaluated at each visit. RESULTS: A total of 384 patients were included in the study, 192 patients in each arm. The mean age of participants was 37.62 + 14.4 years and 225 were women (56%). The improvement in Schirmer's test was significantly better in the SH-trehalose group at 8 weeks (5.26 + 4.3 mm, 95% confidence interval = 4.6-5.9 mm) compared to the SH group (3.71 + 3.9, 95% confidence interval = 3.15-4.28 mm). The TBUT and TFH showed slight improvement at 4 weeks in both groups, but not at 8 weeks. There were no group differences at all-time points in terms of conjunctival staining and OSDI-based grades of DED. CONCLUSION: It was found that treating dry eye with SH-trehalose leads to greater improvement in the Schirmer's values and TBUT after 8 weeks of sustained use in patients with DED, and this was more pronounced in those with severe DED.