NCT01561521已完成3 期
An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Akorn, Inc.
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Ocular Itching at defined time points up to 2 weeks
研究概览
简要总结
The purpose of this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute 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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive bilateral conjunctival allergen challenge (CAC) reaction
排除标准
- •known contraindications or sensitivities to the study medication or its components
- •any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
- •use of disallowed medication during the period indicated prior to the enrollment or during the study
研究组 & 干预措施
AKF-1 0.025%
Experimental
干预措施: AKF-1 (Drug)
AKF-1 0.035%
Experimental
干预措施: AKF-1 (Drug)
AKF-1 0%
Placebo Comparator
干预措施: AKF-1 (Drug)
结局指标
主要结局
Ocular Itching at defined time points up to 2 weeks
时间窗: Baseline to day 14
Ocular Redness at defined time points up to 2 weeks
时间窗: Baseline to day 14
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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