NCT01128556已完成4 期
The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
North Texas Institute for Clinical Trials1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- measurement of Wheal and Flare response from histamine skin-prick testing
研究概览
简要总结
To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the measurement of the wheal and flare from histamine skin prick testing. This is an open label, two-week, post-marketing study conducted on histamine responsive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, 18 to 65 years of age
- •Patients must demonstrate a positive reaction to a Histamine skin-prick test. Manifested by a histamine-induced wheal of >3mm in diameter over the normal saline control after 15 minutes of elapsed time
排除标准
- •Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)
- •Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1
- •Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results
- •Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy
- •Known hypersensitivity to the investigational product or to drugs with similar chemical properties
- •Pregnancy and/or breast feeding
- •Use of antihistamines, NSAIDS, steroids, or other drugs which may affect the skin-response
- •Use of any medications or agents that are not specified above that may confound the interpretation of the results
研究组 & 干预措施
Bepreve
Experimental
topical ocular treatment as indicated
干预措施: Bepreve (Drug)
Bepreve
Experimental
topical ocular treatment as indicated
干预措施: Refresh Tears (Drug)
结局指标
主要结局
measurement of Wheal and Flare response from histamine skin-prick testing
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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