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

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.

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Key information

Conditions

Congenita Nasolacrimal Duct Obstruction Ocular Discharge Preterm Neonates

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Neonatology, Children University Hospital of Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Euphrasia Officinalis Preparation

Drug

At inclusion, before the start of the therapy, a bacterial/viral and chlamydial conjunctival swab is conducted. Afterwards, both eyes of neonates are washed four times a day (i.e., every six hours) with NaCl 0.9%. Subsequently, a drop of Euphrasia is placed into the lower conjunctival sac of each eye, and followed by a lacrimal sac digital massage. If no ocular discharge is apparent for over 24 hours, the therapy is stopped. In case of worsening of symptoms or a positive swab without any improvement of symptoms an antibiotic therapy is initiated: tobramycin (Tobrex 0.3% eye drops, Novartis Pharma Switzerland). An additional swab is performed at 96 hours (i.e. at the end of the study).

Placebo

Drug

At inclusion, before the start of the therapy, a bacterial/viral and chlamydial conjunctival swab is conducted. Afterwards, both eyes of neonates are washed four times a day (i.e., every six hours) with NaCl 0.9%. Subsequently, a drop of placebo is placed into the lower conjunctival sac of each eye, and followed by a lacrimal sac digital massage. If no ocular discharge is apparent for over 24 hours, the therapy is stopped. In case of worsening of symptoms or a positive swab without any improvement of symptoms an antibiotic therapy is initiated: tobramycin (Tobrex 0.3% eye drops, Novartis Pharma Switzerland). An additional swab is performed at 96 hours (i.e. at the end of the study).

Primary outcomes

Number of patients with treatment success at 96 hours

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct - a Randomized Double-blind Controlled Trial

Acronym: Euphrasia

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Oct 10, 2019
Registry last updated: Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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