Efficacy of rebamipide 2%, of an autologous serum and of a combination of both at improving the ocular symptoms of hyposecretion dry eye: a randomized open crossover controlled pilot study

Abstract

Objective: To evaluate the efficacy of rebamipide 2%, of an autologous serum and of the combination of both at improving OSDI scores in patients with hyposecretion dry eye.
Methods: A randomized open crossover controlled pilot study including 42 eyes (21 subjects) who were randomized to treatment with autologous serum (AS), rebamipide (R) and combined therapy (ASR). Efficacy was evaluated in terms of OSDI score, tear break up time (BUT), flourescein staining, rose bengal staining and Schirmer I test.
Results: Per-protocol-analysis in therapies with R and ASR: OSDI scores evidenced significant differences when baseline values were compared with those obtained on day 90 (p <0.01), unlike AS, which showed no differences. When therapies were compared, no differences were found on day 90. With R therapy, Schirmer I test and rose bengal evidenced significant differences between baseline values and those obtained on day 90 (p <0.05). Intent-to-treat analysis revealed significant differences only with R in OSDI score at baseline vs day 90 (p <0.05). However, no differences between therapies were found for this variable, while there were significant differences for R with Schirmer test and rose bengal (p <0.05).
Conclusions: Treatment with rebamipide was efficacious at improving the symptoms of dry eye. With R therapy there was an objective improvement in the results obtained with Schirmer test and rose bengal. Since this was a pilot study, results should be appreciated with caution; randomized controlled trials will be required to evaluate the effect of rebamipide on this population.

Key words: dry eye, rebamipide, autologous serum, Sjögren syndrome.