AG-920(阿替卡因)眼科溶液:一项针对儿科患者局部麻醉效果和安全性的蒙面主动对照评估。

IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Journal of Ocular Pharmacology and Therapeutics Pub Date : 2024-06-01 Epub Date: 2024-04-22 DOI:10.1089/jop.2023.0187
Victor H Gonzalez, Martin Uram, Audrey Schupp, Michelle Widmann, Gary D Novack
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引用次数: 0

摘要

目的:以前曾在成人中评估过一种新型局部眼用麻醉剂(AG-920 无菌眼用溶液,8%)的安全性和有效性。出于临床和监管目的,我们在儿童中对这种新型药剂进行了评估。研究方法这是一项在美国一家私人视网膜诊所对健康儿童受试者进行的 3 期随机、主动对照、单掩蔽、平行组设计研究。在 60 名接受眼科检查的儿童中,比较了 AG-920 与 0.5% 盐酸普鲁卡因眼科溶液的安全性和麻醉效果。主要疗效终点是研究人员是否能够进行眼科检查。研究结果在每个治疗组的所有受试者中,研究人员都能在不使用额外局麻药的情况下进行眼科检查。本研究未报告任何不良事件。研究用眼和同组用眼在用药后均无明显变化,两组治疗效果相似。两个治疗组所有受试者的所有外部眼部检查均正常。结论在年龄为 7 个月到 11 岁以上的儿童群体中,AG-920 与市场上销售的普鲁卡因在进行眼科检查而无需额外局部麻醉方面具有同等疗效。此外,AG-920 的耐受性良好,并且没有发现具有临床意义的安全性问题。
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AG-920 (Articaine) Ophthalmic Solution: A Masked, Active-Controlled Evaluation of Its Local Anesthetic Efficacy and Safety in Pediatric Patients.

Purpose: The safety and efficacy of a novel topical ocular anesthetic (AG-920 sterile ophthalmic solution, 8%) was previously evaluated in adults. For both clinical and regulatory purposes, this new agent was evaluated in children. Methods: This was a Phase 3, randomized, active-controlled, single-masked, parallel-group design study in healthy pediatric subjects performed at a private practice retina clinic in the United States. The safety and anesthetic efficacy of AG-920 was compared with proparacaine hydrochloride ophthalmic solution 0.5% in 60 children undergoing ophthalmic examinations. The primary efficacy endpoint was whether the investigator was able to perform the eye examination. Results: In all subjects in each treatment group, the investigator was able to perform the eye examination without additional local anesthetic. There were no adverse events reported in this study. In both the study eye and fellow eye, there were no notable changes after dosing, and both treatment groups were similar. All external eye exams in all subjects in both treatment groups were normal. Conclusions: In this pediatric population aged 7 months to >11 years, AG-920 was therapeutically equivalent to marketed proparacaine with respect to having an ophthalmic examination performed without needing additional local anesthetic. Further, AG-920 was well tolerated, and there were no clinically significant safety findings.

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来源期刊
CiteScore
4.60
自引率
4.30%
发文量
72
审稿时长
1 months
期刊介绍: Journal of Ocular Pharmacology and Therapeutics is the only peer-reviewed journal that combines the fields of ophthalmology and pharmacology to enable optimal treatment and prevention of ocular diseases and disorders. The Journal delivers the latest discoveries in the pharmacokinetics and pharmacodynamics of therapeutics for the treatment of ophthalmic disorders. Journal of Ocular Pharmacology and Therapeutics coverage includes: Glaucoma Cataracts Retinal degeneration Ocular infection, trauma, and toxicology Ocular drug delivery and biotransformation Ocular pharmacotherapy/clinical trials Ocular inflammatory and immune disorders Gene and cell-based therapies Ocular metabolic disorders Ocular ischemia and blood flow Proliferative disorders of the eye Eyes on Drug Discovery - written by Gary D. Novack, PhD, featuring the latest updates on drug and device pipeline developments as well as policy/regulatory changes by the FDA.
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