Advances in Therapy ( IF 3.4 ) Pub Date : 2022-10-07 , DOI: 10.1007/s12325-022-02295-y
Rita Mencucci 1 , Thomas Ach 2 , Anja Liekfeld 3 , Antonio Scialdone 4 , Claudine Civiale 5 , Maria Grazia Mazzone 5 , Aldo Caporossi 6
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Introduction
To demonstrate efficacy and safety of an ophthalmic hydrogel formulation of netilmicin/dexamethasone, containing xanthan gum twice a day (b.i.d.) versus netilmicin/dexamethasone eye drops four times a day (q.i.d) to treat inflammation and prevention of infection after cataract surgery.
Methods
Patients undergoing phacoemulsification with intraocular lens implantation (IOL) were randomised in two groups: group 1, twice daily (b.i.d.) dexamethasone 0.1%/netilmicin 0.3% (Netildex) ophthalmic gel; group 2, four times daily (q.i.d.) dexamethasone 0.1%/netilmicin 0.3% (Netildex) eye drops. Both treatments were administered for 14 days after surgery. Patients were evaluated before surgery, on the day of surgery and at 1, 7, 15 and 60 postoperative days. The primary efficacy endpoint was evaluation of cellularity and flare in the anterior chamber through slit-lamp biomicroscopy 7 days after surgery. Secondary endpoints included: presence of signs/symptoms of postoperative ocular inflammation and incidence of infection.
Results
One hundred seventy-three patients were randomised and 168 were evaluable. Flare and cellularity were resolved at day 7 in 92.5% of patients and almost completely by day 15. In both intent to treat (ITT) and per-protocol (PP) populations, the efficacy analysis demonstrated that the gel formulation administered twice a day was non-inferior to the eye drops administered four times a day. For ITT analysis, the lower limit of the 97.5% confidence interval (− 0.0535) was greater than the non-inferiority limit of -0.10. For the PP analysis, the lower limit of the 97.5% confidence interval (− 0.0526) was greater than the non-inferiority limit of − 0.10. The patient's global tolerability and reported symptoms were similar between treatment groups. No microbial load and no safety events were observed.
Conclusions
Efficacy of the gel reduced posology (twice a day) is not inferior to four times a day eye drops. Both treatments were well tolerated and efficacious. The new reduced posology hydrogel formulation may improve patient compliance and quality of life.
Trial Registration
Eudract: 2016-0021138-63; ClinicalTrial.gov: NCT029738880.
中文翻译:
![](https://scdn.x-mol.com/jcss/images/paperTranslation.png)
含有地塞米松/奈替米星的眼用水凝胶的减量预防和治疗白内障手术后眼部炎症:疗效和耐受性
介绍
为了证明含有黄原胶的奈替米星/地塞米松眼科水凝胶制剂的有效性和安全性,每天两次(bid)与奈替米星/地塞米松滴眼液每天四次(qid)治疗炎症和预防白内障手术后的感染。
方法
接受人工晶状体植入术 (IOL) 超声乳化术的患者随机分为两组:第 1 组,每天两次(bid)地塞米松 0.1%/netilmicin 0.3%(Netildex)眼用凝胶;第 2 组,每日四次 (qid) 地塞米松 0.1%/netilmicin 0.3% (Netildex) 滴眼液。两种治疗均在手术后进行 14 天。在手术前、手术当天以及术后 1、7、15 和 60 天对患者进行评估。主要疗效终点是在手术后 7 天通过裂隙灯生物显微镜评估前房的细胞结构和闪光。次要终点包括:存在术后眼部炎症的体征/症状和感染发生率。
结果
173 名患者被随机分组,其中 168 名可评估。在第 7 天,92.5% 的患者的红斑和细胞增多得到解决,到第 15 天几乎完全消失。在意向治疗 (ITT) 和符合方案 (PP) 人群中,疗效分析表明,每天给药两次的凝胶制剂是不劣于每天四次滴眼药水。对于 ITT 分析,97.5% 置信区间的下限 (− 0.0535) 大于非劣效性限值 -0.10。对于 PP 分析,97.5% 置信区间的下限 (− 0.0526) 大于非劣效性限值 − 0.10。患者的总体耐受性和报告的症状在治疗组之间相似。没有观察到微生物负荷和安全事件。
结论
凝胶减少剂量(每天两次)的功效不亚于每天四次滴眼液。两种治疗都具有良好的耐受性和有效性。新的减量水凝胶配方可以提高患者的依从性和生活质量。
试用注册
Eudract:2016-0021138-63;ClinicalTrial.gov:NCT029738880。