NCT01470664已完成2 期
A Proof-of-Concept, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Adenoviral Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Adenoviral eradication and clinical resolution of the infection
研究概览
简要总结
This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute adenoviral 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have a clinical diagnosis of suspected acute adenoviral conjunctivitis in at least one eye.
排除标准
- •Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle.
研究组 & 干预措施
FST-100
Experimental
干预措施: FST-100 (Drug)
FST-100 (Component #1)
Experimental
干预措施: FST-100 (Component #1) (Drug)
FST-100 Vehicle
Placebo Comparator
干预措施: FST-100 Vehicle (Drug)
结局指标
主要结局
Adenoviral eradication and clinical resolution of the infection
时间窗: 6-7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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