Pall Brian, Gomes Paul, Yi Frank, Torkildsen Gail
Johnson & Johnson Vision, Jacksonville, FL.
Ora, Inc, Andover, MA.
Cornea. 2019 Jun;38(6):713-717. doi: 10.1097/ICO.0000000000001911.
A contact lens (CL)-based drug delivery system for therapeutic delivery of the antihistamine ketotifen was tested in 2 parallel, conjunctival allergen challenge-based trials.
Both trials employed the same multicenter, randomized, placebo-controlled protocol. Test lenses were etafilcon A with 0.019 mg ketotifen; control lenses were etafilcon A with no added drug. Subjects were randomized into 3 treatment groups. Group 1 received test lens in one eye and control lens in the contralateral eye; the eye chosen to receive test lens was randomly selected in a 1:1 ratio. Group 2 received test lenses bilaterally, and group 3 received control lenses bilaterally. Allergen challenges were conducted on 2 separate visits: following lens insertion, the subjects were challenged at 15 minutes (to test onset) and 12 hours (to test duration). The primary endpoint was ocular itching measured using a 0 to 4 scale with half-unit steps. Secondary endpoints included ciliary, conjunctival, and episcleral hyperemia.
The mean itching scores were lower for eyes wearing the test lens as compared to those that received control lenses, indicating that the test lens effectively reduced allergic responses. Mean differences in itching were statistically and clinically significant (mean score difference ≥ 1) at both onset and duration for both trials.
This large-scale assessment (n = 244) is the first demonstration of efficacy for CL delivery of a therapeutic for ocular allergy. Results are comparable to direct topical drug delivery and suggest that the lens/ketotifen combination can provide a means of simultaneous vision correction and treatment for CL wearers with ocular allergies.
在两项基于结膜过敏原激发试验的平行试验中，对一种用于抗组胺药酮替芬治疗性给药的隐形眼镜（CL）给药系统进行了测试。
两项试验均采用相同的多中心、随机、安慰剂对照方案。测试镜片为含0.019 mg酮替芬的依他氟烷A；对照镜片为未添加药物的依他氟烷A。受试者被随机分为3个治疗组。第1组一只眼睛佩戴测试镜片，对侧眼睛佩戴对照镜片；以1:1的比例随机选择接受测试镜片的眼睛。第2组双侧佩戴测试镜片，第3组双侧佩戴对照镜片。在两次单独的就诊时进行过敏原激发试验：镜片插入后，在15分钟（测试起效）和12小时（测试持续时间）对受试者进行激发试验。主要终点是使用0至4级半单位步长量表测量的眼部瘙痒。次要终点包括睫状、结膜和巩膜上充血。
与佩戴对照镜片的眼睛相比，佩戴测试镜片的眼睛平均瘙痒评分更低，表明测试镜片有效地降低了过敏反应。两项试验在起效和持续时间时瘙痒的平均差异在统计学和临床上均具有显著性（平均评分差异≥1）。
这项大规模评估（n = 244）首次证明了CL给药治疗眼部过敏的疗效。结果与直接局部给药相当，表明镜片/酮替芬组合可为患有眼部过敏的CL佩戴者提供同时进行视力矫正和治疗的方法。
