NCT00881673撤回2 期
A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge (CAC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC.
研究概览
简要总结
The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen Challenge (CAC).
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
- 是
入选标准
- •Have a positive bilateral CAC reaction (>2 itching and > conjunctival redness) to cat hair, cat dander, dust mites, cockroaches and/or dog dander within 10 minutes of instillation of the last titration of allergen at Visit 1
排除标准
- •Have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)
研究组 & 干预措施
1
Experimental
干预措施: AL38583 Ophthalmic Solution (Drug)
2
Active Comparator
干预措施: Maxidex (Drug)
3
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC.
时间窗: 15 days
次要结局
- Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC(15 days)
研究者
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