Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct - a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of patients with treatment success at 96 hours
研究概览
简要总结
Congenital nasolacrimal duct obstruction (CNLDO) occurs in approximately 10 to 20% of all term newborns, and is the most common cause of persistent tearing and ocular discharge in children. CNLDO causes symptoms in up to 6% of children during the first year of life. The first clinical signs appear during the first month of life in 95% of cases and usually consist of tearing and debris on the eyelashes ("mattering"). Mucopurulent eye discharge occurs commonly in infants with CNLDO and, in the absence of other signs of infection, suggests bacterial overgrowth in the stagnant tear pool of the lacrimal sac.
This study investigates whether early administration of Euphrasia eye drops (Weleda AG, Arlesheim) in preterm neonates presenting with first ocular discharge with or without tearing and reddened eye fosters the resolution of the ocular discharge and reduces the need for topical antibiotic therapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates (with a gestational age of 24 to 37 weeks)
- •Presenting with first signs of a congestion of the nasolacrimal duct, i.e. white, yellow, or green ocular discharge with or without tearing and reddened eye.
- •Written informed consent by the parents or legal guardians
排除标准
- •Congenital abnormalities of the eye
- •Ophtalmia neonatorum
- •Severe asphyxia
- •Intracranial bleeding (intraventricular hemorrhage ≥ grade III)
研究组 & 干预措施
Euphrasia arm
Euphrasia eye drops® (Weleda AG, Arlesheim) is administrated at a dose of one drop in each eye four times a day over a period of 96 hours.
干预措施: Euphrasia Officinalis Preparation (Drug)
Placebo arm
Placebo (0.9% NaCl) is administrated at a dose of one drop in each eye four times a day over a period of 96 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with treatment success at 96 hours
时间窗: 96 hours
Treatment success is defined as no ocular discharge at 96 hours and no use of topical antibiotic therapy during the 96-hour intervention period
次要结局
未报告次要终点