Shigeru Kinoshita1, Saki Awamura2, Norihiro Nakamichi2, Hiroyuki Suzuki2, Kazuhide Oshiden2, Norihiko Yokoi3. 1. Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. Electronic address: shigeruk@koto.kpu-m.ac.jp. 2. Otsuka Pharmaceutical Company Ltd, Tokyo, Japan. 3. Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
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 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 that were not thought to be drug related were observed in 6 patients. The 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 is 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.
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 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 that were not thought to be drug related were observed in 6 patients. The 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 is effective in improving both the objective signs and subjective symptoms of dry eyepatients for at least 52 weeks. In addition, 2% rebamipide treatment was generally well tolerated.