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

University of Bern

Status and phase: Completed; Phase 3

Conditions: Ocular Discharge; Preterm Neonates; Congenita Nasolacrimal Duct Obstruction

Treatments: Drug: Placebo; Drug: Euphrasia Officinalis Preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT04122300

2010DR4186

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

Euphrasia arm

Experimental group

Description:

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.

Treatment:

Drug: Euphrasia Officinalis Preparation

Placebo arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo