NCT01156025已完成2 期
Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- efficacy of GV550
研究概览
简要总结
The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female aged from 18 to 80 years old
- •Acute adenoviral keratoconjunctivitis
排除标准
- •Active ocular allergy
- •Ocular herpès disease
- •History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit
研究组 & 干预措施
GV550
Experimental
(Ganciclovir 1.5 mg/g ophtalmic gel)
干预措施: GV550 (Drug)
Placebo
Placebo Comparator
Placebo ophtalmic gel
干预措施: placebo (Drug)
结局指标
主要结局
efficacy of GV550
时间窗: D0 to D4
* The evolution of the inflammation * The virus load by quantitative PCR
次要结局
- efficacy of GV550
- Ocular safety
- Systemic safety
研究者
研究点 (1)
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