A Multicenter, Open-Label, 52-Week Study of 2% Rebamipide (OPC-12759) Ophthalmic Suspension in Patients with Dry Eye – Accepted Manuscript

Abstract: Purpose: To investigate the efficacy and safety of 2% rebamipide ophthalmic suspension administered 4 times daily for 52 weeks in patients with dry eye.Design: Multicenter (17 sites), open-label single-arm study.Methods: A total of 154 patients with dry eye were enrolled in this study. After a 2-week screening period, patients received 2% rebamipide, instilled as 1 drop in each eye, 4 times daily for 52 weeks. The signs and symptoms measures were assessed at baseline, at weeks 2 and 4, and at every 4 weeks thereafter. The objective signs were fluorescein corneal staining score, lissamine green conjunctival staining score, and tear film break-up time, while subjective symptoms were dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision). The safety variable was the occurrence of adverse events.Results: For all objective signs and subjective symptoms, the scores significantly improved at week 2 compared with at baseline (P < .001, paired t-test). Interestingly, further improvements of those scores were observed at every visit up to week 52. No deaths were reported, yet serious adverse events which were not thought to be drug-related were observed in 6 patients. Incidence of any of the adverse events did not markedly increase throughout the 52-week treatment period.Conclusion: The results of this study show that 2% rebamipide was effective in improving both the objective signs and subjective symptoms of dry eye patients for at least 52 weeks. In addition, 2% rebamipide treatment was generally well-tolerated.