Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23.
To investigate the dose response for efficacy of 1% and 2% rebamipide ophthalmic suspension compared with placebo in patients with dry eye.
A randomized, double-masked, multicenter, placebo-controlled, parallel-group, dose-response phase II study.
A total of 308 patients with dry eye.
After a 2-week screening period, patients were randomized to receive placebo or 1% rebamipide or 2% rebamipide administered as 1 drop in each eye 4 times daily for 4 weeks.
The primary objective end point was change in fluorescein corneal staining (FCS) score from baseline to last observation carried forward (LOCF). Secondary objective end points were lissamine green conjunctival staining (LGCS) score, tear film break-up time (TBUT), and the Schirmer's test. Secondary subjective end points included dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision) score and patients' overall treatment impression score.
Rebamipide dose response was observed in FCS, LGCS, and TBUT scores. Both 1% and 2% rebamipide were significantly more effective than the placebo in terms of the change from baseline to LOCF for FCS, LGCS, and TBUT scores. There was no significant difference between the rebamipide and placebo groups from baseline to LOCF in Schirmer's test values, and dose response was not observed. In the predefined dry eye subpopulation with a baseline FCS score of 10 to 15, the mean change from baseline in the 2% rebamipide group was larger than that in the 1% rebamipide group. Change from baseline to LOCF for all 5 dry eye-related ocular symptom scores and patients' overall treatment impression showed significant improvements in the 1% and 2% rebamipide groups compared with the placebo group, except for photophobia in the 1% rebamipide group. No deaths or drug-related serious adverse events occurred in any treatment group. The incidence of ocular abnormalities was similar across the rebamipide and placebo groups.
Rebamipide was effective in treating both objective signs and subjective symptoms of dry eye and were well tolerated in this 4-week study. Although 1% and 2% rebamipide were both efficacious, 2% rebamipide may be more effective than 1% rebamipide in some measures.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
研究 1%和 2%瑞巴派特滴眼液与安慰剂相比在干眼症患者中的疗效剂量反应。
一项随机、双盲、多中心、安慰剂对照、平行组、剂量反应 II 期研究。
共 308 例干眼症患者。
经过 2 周的筛选期后，患者被随机分配接受安慰剂或 1%瑞巴派特或 2%瑞巴派特，每天每只眼滴 4 次，持续 4 周。
主要终点是从基线到最后一次观察（LOCF）的荧光素角膜染色（FCS）评分变化。次要终点包括丽丝胺绿结膜染色（LGCS）评分、泪膜破裂时间（TBUT）和泪液分泌试验（Schirmer's test）。次要主观终点包括干眼相关眼部症状（异物感、干燥、畏光、眼痛和视力模糊）评分和患者整体治疗印象评分。
在 FCS、LGCS 和 TBUT 评分中观察到瑞巴派特的剂量反应。与安慰剂组相比，1%和 2%瑞巴派特在 FCS、LGCS 和 TBUT 评分的基线至 LOCF 变化方面均显著更有效。在基线至 LOCF 的 Schirmer's test 值方面，瑞巴派特组和安慰剂组之间没有显著差异，也没有观察到剂量反应。在基线 FCS 评分为 10 至 15 的预先定义的干眼症亚组中，2%瑞巴派特组的基线至 LOCF 的平均变化大于 1%瑞巴派特组。与安慰剂组相比，1%和 2%瑞巴派特组的所有 5 项干眼相关眼部症状评分和患者整体治疗印象均有显著改善，除 1%瑞巴派特组的畏光外。在任何治疗组中均未发生死亡或与药物相关的严重不良事件。在瑞巴派特组和安慰剂组之间，眼部异常的发生率相似。
瑞巴派特在治疗干眼症的客观体征和主观症状方面均有效，且在这项为期 4 周的研究中耐受性良好。虽然 1%和 2%瑞巴派特均有效，但在某些指标上，2%瑞巴派特可能比 1%瑞巴派特更有效。
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