Efficacy and safety of 1% and 2% rebamipide clear solution in dry eye disease: a multicenter randomized trial

초록

BackgroundTo evaluate the efficacy of 1% and 2% rebamipide clear solution in the treatment of dry eye disease (DED).MethodsTwo hundred twenty patients with DED were randomly assigned to one of three groups: the 1% rebamipide, 2% rebamipide, or placebo (eye drops containing the same ingredients, except for the active components). Each eye drop was instilled four times daily for 12 weeks. Changes in tear film break-up time (TBUT), corneal and conjunctival staining score, Schirmer 1 test, and the Ocular Surface Disease Index (OSDI) from baseline to 12-week visit between the study groups were compared for efficacy assessment.ResultsThe mean age of study patients was 43.8 & PLUSMN;14.2 years. The 1% and 2% rebamipide groups showed greater improvement in TBUT (1.99 & PLUSMN;1.87 and 2.02 & PLUSMN;2.21 s) at 12 weeks from baseline than the placebo group (1.25 & PLUSMN;2.93 s). The 2% rebamipide group showed greater improvement in the corneal staining score (- 3.15 & PLUSMN;2.00) at 12 weeks from baseline than the placebo group (- 2.85 & PLUSMN;1.80). The 1% and 2% rebamipide groups showed improvement in Schirmer 1 test (1.27 & PLUSMN;3.86 and 1.50 & PLUSMN;4.14 mm) at 12 weeks of treatment, but not the placebo group (0.55 & PLUSMN;2.99 mm). Both the rebamipide groups and the placebo group showed significantly improved OSDI after treatment for 12 weeks; however, there was no significant difference among the three groups.Conclusions1% and 2% rebamipide clear solutions are an effective therapeutic option for improving TBUT and tear volume, and stabilizing the corneal staining score in DED.

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