Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct

Phase 3

Completed

• Conditions: Congenita Nasolacrimal Duct Obstruction; Ocular Discharge; Preterm Neonates
• Interventions: Drug: Placebo; Drug: Euphrasia Officinalis Preparation

• Registration Number: NCT04122300
• Lead Sponsor: University of Bern

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-22
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-16
• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Last Update Submitted: 2019-10-08
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 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

Exclusion Criteria

• Congenital abnormalities of the eye
• Ophtalmia neonatorum
• Severe asphyxia
• Sepsis
• Intracranial bleeding (intraventricular hemorrhage ≥ grade III)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	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.
Euphrasia arm	Euphrasia Officinalis Preparation	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment success at 96 hours	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

Trial Locations

Locations (1)

Department of Neonatology, Children University Hospital of Bern; 🇨🇭 Bern, Switzerland