一日一次地那非前列腺素滴眼液 0.3%用于预防和治疗白内障手术后眼部炎症和疼痛：3 期研究。
Once-daily nepafenac ophthalmic suspension 0.3% to prevent and treat ocular inflammation and pain after cataract surgery: phase 3 study.
机构信息
From Alterman, Modi & Wolter (Modi), Poughkeepsie, and the Manhattan Eye, Ear and Throat Hospital (Fong), New York, New York; Lehmann Eye Center (Lehmann), Nacogdoches, Nethery Eye Associates (Nethery), and Alcon Research, Ltd. (Sager), Fort Worth, and Texan Eye, PA (Walters), Austin, Texas; Scott & Christie & Assoc., PC (Christie), Cranberry Township, and Eye Care Specialists (Reiser), Kingston, Pennsylvania; Eastside Westside Research Center (Roel), Spartanburg, South Carolina, USA; Josa Andras Hospital (Tsorbatzoglou), Nyíregyháza, Hungary; Stockholm Eye Clinic (Philipson), Stockholm, Sweden; Clinica Oculistica (Traverso), Di.N.O.G.M.I., University of Genoa, Genoa, Italy.
From Alterman, Modi & Wolter (Modi), Poughkeepsie, and the Manhattan Eye, Ear and Throat Hospital (Fong), New York, New York; Lehmann Eye Center (Lehmann), Nacogdoches, Nethery Eye Associates (Nethery), and Alcon Research, Ltd. (Sager), Fort Worth, and Texan Eye, PA (Walters), Austin, Texas; Scott & Christie & Assoc., PC (Christie), Cranberry Township, and Eye Care Specialists (Reiser), Kingston, Pennsylvania; Eastside Westside Research Center (Roel), Spartanburg, South Carolina, USA; Josa Andras Hospital (Tsorbatzoglou), Nyíregyháza, Hungary; Stockholm Eye Clinic (Philipson), Stockholm, Sweden; Clinica Oculistica (Traverso), Di.N.O.G.M.I., University of Genoa, Genoa, Italy.
出版信息
J Cataract Refract Surg. 2014 Feb;40(2):203-11. doi: 10.1016/j.jcrs.2013.07.042. Epub 2013 Dec 15.
PURPOSE
To evaluate once-daily nepafenac 0.3% to prevent and treat ocular pain and inflammation after cataract surgery.
SETTING
Sixty-five centers in the United States and Europe.
DESIGN
Randomized double-masked vehicle- and active-controlled phase 3 study.
METHODS
Patients received nepafenac 0.3% once daily, nepafenac 0.1% 3 times daily, or their respective vehicles from day -1 to day 14 after cataract extraction. An additional drop of study drug was administered 30 to 120 minutes preoperatively. The primary endpoint was the percentage of patients with a cure for inflammation (score of 0 for both aqueous cells and flare) at day 14.
RESULTS
Of randomized patients, 817 received nepafenac 0.3%, 819 received nepafenac 0.1%, and 200 and 206 received the respective vehicles. Significantly more nepafenac 0.3% patients had no inflammation (68.4% versus 34.0%) and were pain free (91.0% versus 49.7%) at day 14 than vehicle patients (both P<.0001). Nepafenac 0.3% was noninferior to nepafenac 0.1% for inflammation (95% confidence interval [CI], -5.73% to 3.17%) and pain-free rates (95% CI, -3.08% to 2.70%). At all postoperative visits, fewer treatment failures (P≤.0012) and more clinical successes (P ≤ .0264) were observed with nepafenac 0.3% versus vehicle. Nepafenac 0.3% was well tolerated and had a safety profile comparable to that of nepafenac 0.1%.
CONCLUSIONS
Once-daily nepafenac 0.3% was noninferior to nepafenac 0.1% 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery. The safety of nepafenac 0.3% was comparable to that of nepafenac 0.1%, with the added convenience of once-daily dosing.
FINANCIAL DISCLOSURE
Drs. Modi, Lehmann, Walters, Fong, Christie, Roel, Nethery, and Reiser have been paid consultants to Alcon Research, Ltd. Ms. Sager is an employee of Alcon Research, Ltd. Drs. Tsorbatzoglou, Philipson, and Traverso have no financial or proprietary interest in any material or method mentioned.
目的
评估每日一次的那普啡胺 0.3% 预防和治疗白内障手术后眼部疼痛和炎症。
设置
美国和欧洲的 65 个中心。
设计
随机、双盲、载体和活性对照的 3 期研究。
方法
患者接受那普啡胺 0.3% 每日一次、那普啡胺 0.1% 每日三次或各自的载体，从白内障摘除术后第-1 天至第 14 天。在术前 30 至 120 分钟额外滴注研究药物。主要终点是第 14 天炎症缓解（水细胞和闪光评分均为 0）的患者比例。
结果
在随机患者中，817 名接受那普啡胺 0.3%，819 名接受那普啡胺 0.1%，200 名和 206 名接受各自的载体。与载体组患者相比，那普啡胺 0.3% 组患者在第 14 天无炎症（68.4%比 34.0%）和无痛（91.0%比 49.7%）的患者显著更多（均 P<.0001）。那普啡胺 0.3% 对炎症的非劣效性（95%置信区间[CI]，-5.73%至 3.17%）和无疼痛率（95%CI，-3.08%至 2.70%）与那普啡胺 0.1% 相当。在所有术后访视中，与载体组相比，那普啡胺 0.3% 组治疗失败率（P≤.0012）更低，临床成功率（P ≤.0264）更高。那普啡胺 0.3% 耐受性良好，安全性与那普啡胺 0.1% 相当。
结论
每日一次的那普啡胺 0.3% 与每日三次的那普啡胺 0.1% 相比，对白内障手术后眼部炎症和疼痛的预防和治疗非劣效。那普啡胺 0.3% 的安全性与那普啡胺 0.1% 相当，且每日一次给药更为方便。
财务披露
Modi 博士、Lehmann 博士、Walters 博士、Fong 博士、Christie 博士、Roel 博士、Nethery 博士和 Reiser 博士已被 Alcon Research，Ltd. 聘为顾问。Sager 女士是 Alcon Research，Ltd. 的员工。Tsorbatzoglou 博士、Philipson 博士和 Traverso 博士在本文中提到的任何材料或方法均无财务或所有权利益。
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