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

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First Author: A.Morya INDIA

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Abstract Details

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).

Setting:

A randomised clinical -trial registered at Clinical trial registry of India no. CTRI/2020/04/024605 Between Trehalose with sodium hyaluronate versus Sodium hyaluronate in a tertiary eye care centre at All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

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 192 patients patients were included in each arm. The mean age 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.

Conclusions:

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.

Financial Disclosure:

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