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临床试验/NCT00534794
NCT00534794已完成4 期

A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model

Merck Sharp & Dohme LLC1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2007年10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
入组人数
79
试验地点
1
主要终点
Change in Ocular Itch Score From Baseline

研究概览

简要总结

The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Documented history of ocular allergy to cats.
  • Positive skin prick allergen reaction to cat dander.

排除标准

  • Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.
  • History of severe asthma, reactive airway disease or bronchial obstruction.
  • Ocular surgery or trauma in the last year.

研究组 & 干预措施

Elestat

Experimental

干预措施: Elestat (Drug)

Pataday

Active Comparator

干预措施: Pataday (Drug)

结局指标

主要结局

Change in Ocular Itch Score From Baseline

时间窗: 0 hours, 12 hours

Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.

次要结局

  • Ocular Comfort Score at 12 Hours(12 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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