Lichtenstein Steven J, Pasquine Terry A, Edwards Michael R, Wells David T, Gross Robert D, Robertson Stella M
Illinois Eye Center, University of Illinois College of Medicine, Peoria, IL, USA.
J Ocul Pharmacol Ther. 2007 Aug;23(4):366-71. doi: 10.1089/jop.2007.0013.
The aim of this study was to evaluate the safety of olopatadine hydrochloride ophthalmic solution 0.2% in children and adolescents 3-17 years of age.
In this 6-week, randomized, double-masked safety evaluation, eligible subjects with asymptomatic eyes underwent in-office visits at weeks 1, 3, and 6 and were contacted by telephone at weeks 2, 4, and 5. Qualified subjects were assigned randomly in a 2:1 ratio of olopatadine 0.2% to vehicle (identical formation without the active ingredient) for dosing on a once-daily schedule. Safety parameters assessed included adverse events, visual acuity, ocular signs (slit-lamp assessments), dilated fundus examinations, intraocular pressure (IOP), pulse, and blood pressure.
An evaluation of 126 subjects (age range, 3-17) revealed no clinically relevant treatment-related changes in visual acuity, IOP, slit-lamp assessments, fundus examinations, or cardiovascular parameters. All adverse events reported were mild or moderate.
Olopatadine 0.2% administered once-daily for 6 weeks is safe and well tolerated in children and adolescent patients.
本研究旨在评估0.2%盐酸奥洛他定滴眼液在3至17岁儿童及青少年中的安全性。
在这项为期6周的随机双盲安全性评估中，符合条件的无症状眼部受试者在第1、3和6周进行门诊就诊，并在第2、4和5周接受电话随访。合格受试者按2:1的比例随机分配，分别使用0.2%奥洛他定或赋形剂（不含活性成分的相同制剂），每日给药一次。评估的安全参数包括不良事件、视力、眼部体征（裂隙灯检查）、散瞳眼底检查、眼压（IOP）、脉搏和血压。
对126名受试者（年龄范围3至17岁）的评估显示，在视力、眼压、裂隙灯检查、眼底检查或心血管参数方面，未发现与治疗相关的具有临床意义的变化。报告的所有不良事件均为轻度或中度。
0.2%奥洛他定每日给药一次，持续6周，在儿童和青少年患者中是安全且耐受性良好的。
