长效二喹磷酸滴眼溶液 DE-089C 治疗干眼症患者的疗效和安全性：一项随机、双盲、安慰剂对照的 3 期研究。
Efficacy and Safety of the Long-Acting Diquafosol Ophthalmic Solution DE-089C in Patients with Dry Eye: A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study.
机构信息
Department of Ophthalmology, Toho University Omori Medical Center, Toho University Graduate School of Medicine, 6-11-1, Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.
Global Clinical Development and Operations, Product Development Division, Clinical Operations Japan/Asia, Santen Pharmaceutical Co., Ltd., Kita-ku, Ofukacho Osaka, Japan.
出版信息
Adv Ther. 2022 Aug;39(8):3654-3667. doi: 10.1007/s12325-022-02194-2. Epub 2022 Jun 18.
INTRODUCTION
DE-089C is a newly developed long-acting formulation of diquafosol ophthalmic solution with less frequent administration (three times daily) than the currently approved and clinically used diquafosol ophthalmic solution (six times daily), hereinafter referred to as DQS. DE-089C is desirable for achieving better patient adherence in clinical practice for dry eye therapy. The objective of this study was to confirm the efficacy and safety of DE-089C in patients with dry eye compared to placebo.
METHODS
This randomized, multicenter, double-masked, placebo-controlled, parallel-group phase 3 study was conducted in Japan. Patients with aqueous-deficient dry eye satisfying Schirmer's test I results ≤ 5 mm/5 min were included. A total of 337 patients with dry eye were randomized in an equal ratio to treatment with DE-089C or placebo ophthalmic solution, three times daily for 4 weeks. The primary endpoint for efficacy was change in fluorescein corneal staining score from baseline to week 4. The incidence of adverse drug reactions was investigated for safety evaluation.
RESULTS
The background characteristics of patients in the two groups were similar. Primary endpoint of change in fluorescein corneal staining score at week 4 in the DE-089C group was significantly improved compared with the placebo group (least squares mean difference - 0.51, 95% CI - 0.754 to - 0.269, P < 0.0001). The secondary endpoint of the Lissamine green conjunctival staining score was also significantly improved in the DE-089C group compared to that in the placebo group, while other secondary endpoints were not achieved in this study. Commonly (incidence ≥ 1%) reported adverse drug reactions in the DE-089C group were eye irritation (3.6%) and eye discharge (1.8%) with mild severity, and the incidences of these two events were not higher than those in previous clinical studies on DQS.
CONCLUSION
The efficacy and safety of DE-089C administered three times daily at half the dosage of DQS in patients with dry eye were confirmed in this study.
TRIAL REGISTRATION
Japan Pharmaceutical Information Center ID, JapicCTI-205177.
简介
DE-089C 是一种新开发的长效剂型的地夸磷索滴眼溶液，与目前批准和临床使用的地夸磷索滴眼溶液（每日 6 次）相比，给药频率更低（每日 3 次），以下简称 DQS。DE-089C 有望在干眼症治疗的临床实践中实现更好的患者依从性。本研究的目的是确认 DE-089C 在干眼症患者中的疗效和安全性优于安慰剂。
方法
这是一项在日本进行的随机、多中心、双盲、安慰剂对照、平行组 3 期研究。纳入满足 Schirmer 试验 I 结果≤5mm/5min 的水性缺乏性干眼症患者。共有 337 名干眼症患者以 1:1 的比例随机分为 DE-089C 或安慰剂滴眼溶液治疗组，每日 3 次，持续 4 周。疗效的主要终点是从基线到第 4 周时荧光素角膜染色评分的变化。对不良药物反应的发生率进行了安全性评估。
结果
两组患者的背景特征相似。第 4 周时 DE-089C 组的荧光素角膜染色评分变化的主要终点与安慰剂组相比显著改善（最小二乘均数差值-0.51，95%置信区间-0.754 至-0.269，P<0.0001）。DE-089C 组的 Lissamine 绿染色结膜评分的次要终点也显著改善，而其他次要终点在本研究中未达到。DE-089C 组常见（发生率≥1%）报告的不良药物反应为眼部刺激（3.6%）和眼部分泌物（1.8%），均为轻度，这两种事件的发生率与 DQS 之前的临床研究结果相似。
结论
本研究证实了每日 3 次给予干眼症患者半剂量 DQS 的 DE-089C 的疗效和安全性。
临床试验注册
日本药品信息中心 ID，JapicCTI-205177。
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