A Multicenter, Open-Label, 52-Week Study of 2% Rebamipide (OPC-12759) Ophthalmic Suspension in Patients With Dry Eye
A Multicenter, Open-Label, 52-Week Study of 2% Rebamipide (OPC-12759) Ophthalmic Suspension in Patients With Dry Eye
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DOI：
10.1016/j.ajo.2013.11.010
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发表时间：
2014-03-01
影响因子：
4.2
通讯作者：
Yoko, Norihiko
中科院分区：
文献类型：
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作者：
Kinoshita, Shigeru;Awamura, Saki;Yoko, Norihiko
目得：目的：探讨2%瑞巴派特眼用混悬液每日4次连续52周治疗干眼症的有效性和安全性。设计：多中心（17个中心）、开放性、单组研究。在2周的筛选期后，患者接受2%瑞巴派特，每只眼睛滴入1滴，每天4次，持续52周。在基线、第2周和第4周以及此后每4周一次评估体征和症状测量值。客观体征为荧光素角膜染色评分、丽丝胺绿色结膜染色评分和泪膜破裂时间，而主观症状为干眼症相关的眼部症状（异物感、干燥、畏光、眼痛和视物模糊）。安全性变量是不良事件的发生率。结果：对于所有客观体征和主观症状，评分在第2周与基线相比显著改善（P < .001，配对t检验）。有趣的是，在直至第52周的每次访视中观察到这些评分的进一步改善。未报告死亡，但在6例患者中观察到认为与药物无关的严重不良事件。任何不良事件的发生率并没有显着增加，在整个52周的治疗periods.CONCLUSION：本研究的结果表明，2%瑞巴派特是有效的，在改善客观体征和主观症状的干眼症患者至少52周。此外，2%瑞巴派特治疗通常耐受良好。
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.