Friedlaender M H, Harris J, LaVallee N, Russell H, Shilstone J
Department of Ophthalmology, Scripps Clinic, La Jolla, California,
Ophthalmology. 2000 Dec;107(12):2152-7. doi: 10.1016/s0161-6420(00)00349-3.
The trial evaluated the effectiveness of the investigational antihistaminic and antiallergic compound Azelastine Eye Drops (AZE) in the treatment of allergic conjunctivitis using an allergen challenge model.
Randomized, double-blind, placebo-controlled, paired-eye study.
Adults with a history of allergic conjunctivitis (>/=2 years) who were asymptomatic throughout the trial, had a positive skin test (cat dander, grass, or ragweed pollen within the last year), and had a positive conjunctival reaction (score 2+ or more for itching and redness in both eyes on a 0-4 scale) during two separate conjunctival provocation tests (CPT) before randomization.
Eighty patients underwent a 2-week screening period (visits 1 and 2) that included a CPT during visit 1 to establish the allergen threshold dose and a second confirmatory CPT performed at visit 2. Eye symptom assessments for itching (evaluated by patient) and conjunctival redness (evaluated by physician) were performed 5 and 10 minutes after CPT using a 5-point scale (from 0 = none to 4+ = severe). Qualified patients were randomized to receive one drop of AZE (0.015 mg of azelastine hydrochloride) in one eye and one drop of placebo in the other eye 20 minutes before CPT at visit 3 (onset) and 8 or 10 hours before CPT at visit 4 (duration).
Individual severity scores for itching (evaluated by patient) and conjunctival redness (evaluated by physician) for each eye at 3, 5, and 10 minutes after CPT at visits 3 and 4 using a 5-point scale (0 = none to 4+ = very severe).
Each of the 80 randomized patients completed the trial. Mean itching and conjunctival redness scores at visit 3 (onset) were significantly lower (P: < 0.001) in the AZE-treated eyes than in the placebo-treated eyes. At visit 4 (duration), mean itching and conjunctival redness scores (P: </= 0.003) for the 8-hour group and mean itching scores (P: </= 0.001) for the 10-hour group were significantly lower in the AZE-treated eyes than in the placebo-treated eyes. Significant differences in mean tearing and chemosis severity scores were also seen at visit 3 (onset) and visit 4 (duration) in the AZE-treated eyes when compared with the placebo-treated eyes. Treatment with AZE was well tolerated.
Therapy of experimentally induced allergic conjunctivitis with AZE was highly effective, with an onset of action seen within 3 minutes and a duration of effect of at least 8 to 10 hours.
本试验使用过敏原激发模型评估了研究性抗组胺和抗过敏化合物氮卓斯汀滴眼液（AZE）治疗过敏性结膜炎的有效性。
随机、双盲、安慰剂对照、双眼配对研究。
有过敏性结膜炎病史（≥2年）的成年人，在整个试验过程中无症状，皮肤试验呈阳性（过去一年内对猫毛屑、草或豚草花粉过敏），且在随机分组前的两次单独结膜激发试验（CPT）中结膜反应呈阳性（双眼瘙痒和发红评分为2+或更高，评分范围为0-4分）。
80名患者接受了为期2周的筛查期（第1次和第2次就诊），其中第1次就诊时进行CPT以确定过敏原阈值剂量，第2次就诊时进行第二次确认性CPT。在CPT后5分钟和10分钟，使用5分制（从0=无到4+=严重）对瘙痒（由患者评估）和结膜充血（由医生评估）进行眼部症状评估。符合条件的患者在第3次就诊（起效）CPT前20分钟和第4次就诊（持续时间）CPT前8或10小时，随机接受一只眼滴一滴AZE（0.015毫克盐酸氮卓斯汀），另一只眼滴一滴安慰剂。
在第3次和第4次就诊CPT后3、5和10分钟，使用5分制（0=无到4+=非常严重）对每只眼睛的瘙痒（由患者评估）和结膜充血（由医生评估）进行个体严重程度评分。
80名随机分组的患者均完成了试验。在第3次就诊（起效）时，AZE治疗眼的平均瘙痒和结膜充血评分显著低于（P：<0.001）安慰剂治疗眼。在第4次就诊（持续时间）时，8小时组的平均瘙痒和结膜充血评分（P：≤0.003）以及10小时组的平均瘙痒评分（P：≤0.001），AZE治疗眼显著低于安慰剂治疗眼。与安慰剂治疗眼相比，在第3次就诊（起效）和第4次就诊（持续时间）时，AZE治疗眼的平均流泪和结膜水肿严重程度评分也存在显著差异。AZE治疗耐受性良好。
用AZE治疗实验性诱导的过敏性结膜炎非常有效，起效时间在3分钟内，作用持续时间至少为8至10小时。
