A multicenter, open-label, 52-week study of 2% rebamipide (OPC-12759) ophthalmic suspension in patients with dry eye.
OBJECTIVE
To investigate the efficacy and safety of 2% rebamipide ophthalmic suspension administered 4 times daily for 52 weeks in patients with dry eye.


METHODS
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.


CONCLUSIONS
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.
Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. Electronic address: shigeruk@koto.kpu-m.ac.jp.
Shigeru
S
Kinoshita
Otsuka Pharmaceutical Company Ltd, Tokyo, Japan.
Saki
S
Awamura
Otsuka Pharmaceutical Company Ltd, Tokyo, Japan.
Norihiro
N
Nakamichi
Otsuka Pharmaceutical Company Ltd, Tokyo, Japan.
Hiroyuki
H
Suzuki
Otsuka Pharmaceutical Company Ltd, Tokyo, Japan.
Kazuhide
K
Oshiden
Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Norihiko
N
Yokoi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000409:Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000975:Antioxidants / Q000008:administration & dosage* / Q000009:adverse effects; D003315:Cornea / Q000378:metabolism; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D019793:Fluorescein; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D013194:Staining and Labeling; D013535:Suspensions; D013666:Tears / Q000502:physiology; D013997:Time Factors; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
D000975:Antioxidants; D015363:Quinolones; D013535:Suspensions; C052785:rebamipide; D000409:Alanine; D019793:Fluorescein