A Pilot Study Evaluating the Effect of Conjunctival Allergen Challenge (CAC) on Nasal and Ocular Allergic Symptoms Following Allergen Exposure in the Allergen BioCube (ABC) in Subjects With Seasonal Allergic Rhinoconjunctivitis

ORA, Inc.1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2009年9月最近更新: 2010年9月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 120
试验地点: 1
主要终点: Ocular Itching

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC).

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•be at least 18 years of age;
•if female, cannot be pregnant or nursing;
•have a history of ocular and nasal allergy;
•have a positive skin test reaction to ragweed within the past 24 months;
•may/may not have a positive skin test reaction to dust mites within the past 24 months

排除标准

•have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood and Lung Institute classification;
•have a compromised lung function;
•have any ocular condition that could affect the subject's health or the study parameters;
•have any presence of active ocular or sinus infection;
•have significant nasal conditions;
•have any significant illness that could be expected to interfere with the subject's health or with the study parameters;
•use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period;
•have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;