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

1 Department of Ophthalmology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
2 Department of Ophthalmology, AIIMS, Jodhpur, Rajasthan, India

Correspondence Address:
Arvind Kumar Morya,
MS(Gold Medalist), Associate Professor and Unit II Head Glaucoma, Cataract, Refractive, Squint, Paediatric Ophthalmology and Medical Retina Services, Department of Ophthalmology, All India Institute of Medical Sciences, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/tjo.tjo_58_20

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.

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