Objective: Trehalose can protect human corneal epithelial cells in culture from death from desiccation. This study was designed to test the efficacy and safety of trehalose eyedrops in the treatment of moderate to severe dry eye syndrome. Design: A randomized, double-masked, dose-ranging, fellow eye-controlled clinical trial. Participants: Thirty-four patients with moderate to severe dry eye syndrome. Methods: The patients used either 100 or 200 mM trehalose dissolved in saline six times daily in one eye and control saline in the other eye for 4 weeks. Main Outcome Measures: Symptoms and signs in both eyes were recorded separately at baseline, 2 weeks, and 4 weeks. Results: Fluorescein and rose bengal staining scores of the ocular surface improved at both 2 weeks and 4 weeks in the eyes with 100 and 200 mM trehalose, compared with eyes with control saline (P = 0.0030 to P < 0.0001, respectively, Mann-Whitney U test). Tear film breakup time became significantly longer at 2 weeks and 4 weeks with 100 mM trehalose (P = 0.0024 and P < 0.0001, respectively), but not with 200 mM trehalose. No adverse effect attributable to trehalose solution was noted. Conclusions: Trehalose solution was an effective and safe eyedrop for the treatment of moderate to severe dry eye syndrome in this group of patients.
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