Abstract：
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.
摘要：
目的：新型局部眼部麻醉剂（AG-920无菌眼用溶液，8％）先前在成人中进行了评估。出于临床和监管目的，这种新的药物在儿童中进行了评估。方法：这是一个阶段3，随机，主动控制，单面具,在美国一家私人视网膜诊所进行的健康儿科受试者的平行组设计研究。在60例接受眼科检查的儿童中，比较了AG-920与0.5％盐酸丙对卡因眼用溶液的安全性和麻醉效果。主要疗效终点是研究者是否能够进行眼部检查。结果：在每个治疗组的所有受试者中，研究者无需额外的局部麻醉即可进行眼部检查.在这项研究中没有报告不良事件。在研究之眼和同伴之眼中，给药后没有明显变化，两个治疗组相似。两个治疗组的所有受试者的所有外眼检查均正常。结论：在7个月至>11岁的儿科人群中，AG-920在不需要额外局部麻醉剂的情况下进行眼科检查，与市售的丙对卡因在治疗上等效。Further,AG-920耐受性良好，并且没有临床上显著的安全性发现.
