NCT00985075已完成不适用
A Pilot Study Evaluating the Signs and Symptoms of Seasonal Allergic Rhinitis and Conjunctivitis Following Allergen Exposure in the Allergen BioCube
ORA, Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Conjunctival Redness
研究概览
简要总结
The objective of this study is to evaluate ocular and nasal signs and symptoms in patients with seasonal allergic rhinoconjunctivitis following allergen exposure in the Allergen BioCube.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 and a positive skin test reaction to one of the allergens tested 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;
结局指标
主要结局
Conjunctival Redness
时间窗: At specified timepoints for up to 3 hours
Ocular Itching
时间窗: At specified timepoints for up to 3 hours
Total Ocular Symptom Score (TOSS)of ocular itching and redness
Total Nasal Symptom Score (TNSS) of nasal symptoms
次要结局
- Ciliary and episcleral redness(At specified timepoints for up to 3 hours)
- Chemosis(At specified timepoints for up to 3 hours)
- Lid Swelling(At specified timepoints for up to 3 hours)
- Tearing(At specified timepoints for up to 3 hours)
- Nasal Itching(At specified timepoints for up to 3 hours)
- Sneezing(At specified timepoints for up to 3 hours)
- Rhinorrhea(At specified timepoints for up to 3 hours)
- Nasal Congestion(At specified timepoints for up to 3 hours)
研究者
研究点 (1)
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