EUCTR2007-002455-16-DE进行中（未招募）不适用
Efficacy and safety of GV 550 in acute adenoviral keratoconjunctivitis
aboratoires Théa0 个研究点目标入组 80 人开始时间: 2007年7月31日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent
- •Male or female aged from 18 to 80 years old
- •Acute adenoviral keratoconjunctivitis clinically diagnosed on the basis of:
- •First episode
- •With an history of unilateral occurrence
- •Recent (first symptoms lasting less than 3 days)
- •Conjunctival injection
- •Without infiltrates
- •Without purulent secretion
- •With positive rapid test diagnosis (RPS Adeno-detector®)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active ocular allergy, Ocular herpes disease
- •History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit
- •Any relevant ocular anomaly interfering with ocular surface: chemical burns, corneal distrophy, orbital radiotherapy, progressive involvement after traumatism, etc…….
- •Best far corrected visual acuity = 1/10
- •By questioning: Any known medical or surgical history, disorder or disease such as acute or chronic severe organic disease
- •Known hypersensitivity to one of the components of the study products.
- •Pregnancy, lactation for women
- •Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance, man who is not using a local contraceptive method such as condom).
研究者
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