Eye Clinic, Department of Neuroscience, Psychology, Pharmacology and Child Health (NEUROFARBA), University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Augenklinik Und Poliklinik, Würzburg, Germany.
Adv Ther. 2022 Dec;39(12):5474-5486. doi: 10.1007/s12325-022-02295-y. Epub 2022 Oct 7.
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.
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.
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.
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.
Eudract: 2016-0021138-63; ClinicalTrial.gov: NCT029738880.
为了验证含有 xanthan 胶的妥布霉素/地塞米松眼科水凝胶制剂（每日两次，b.i.d.）与妥布霉素/地塞米松滴眼液（每日四次，q.i.d.）在白内障手术后治疗炎症和预防感染方面的疗效和安全性，将患者随机分为两组：第 1 组，每日两次（b.i.d.）地塞米松 0.1%/妥布霉素 0.3%（Netildex）眼用凝胶；第 2 组，每日四次（q.i.d.）地塞米松 0.1%/妥布霉素 0.3%（Netildex）滴眼液。两组均在术后 14 天内进行治疗。患者在术前、手术当天以及术后第 1、7、15 和 60 天进行评估。主要疗效终点为术后第 7 天通过裂隙灯生物显微镜评估前房细胞和房水闪辉。次要终点包括：术后眼部炎症的体征/症状和感染的发生率。
共有 173 名患者被随机分配，其中 168 名患者可评估。在第 7 天，92.5%的患者的房水闪辉和细胞得到缓解，到第 15 天几乎完全缓解。在意向治疗（ITT）和符合方案（PP）人群中，疗效分析表明，每日两次给药的凝胶制剂与每日四次给药的滴眼液疗效相当。对于 ITT 分析，97.5%置信区间的下限（-0.0535）大于非劣效性下限（-0.10）。对于 PP 分析，97.5%置信区间的下限（-0.0526）大于非劣效性下限（-0.10）。两组患者的总体耐受性和报告的症状相似。未观察到微生物负荷和安全性事件。
减少给药次数（每日两次）的凝胶疗效不劣于每日四次滴眼。两种治疗方法均具有良好的耐受性和疗效。新的减少给药次数的水凝胶制剂可能会提高患者的依从性和生活质量。
Eudract：2016-0021138-63；ClinicalTrials.gov：NCT029738880。
