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

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Neonates; Congenita Nasolacrimal Duct Obstruction; Ocular Discharge
• Intervention / Treatment: Drug: Euphrasia Officinalis Preparation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Neonatology, Children University Hospital of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Euphrasia Officinalis Preparation; 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 Comparator: 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.	Drug: Placebo; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with treatment success at 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	96 hours

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Chair: Ursula Wolf, Institute for complementary and integrative medicine

Publications and helpful links

General Publications

• Meier-Girard D, Gerstenberg G, Stoffel L, Kohler T, Klein SD, Eschenmoser M, Mitter VR, Nelle M, Wolf U. Euphrasia Eye Drops in Preterm Neonates With Ocular Discharge: A Randomized Double-Blind Placebo-Controlled Trial. Front Pediatr. 2020 Aug 11;8:449. doi: 10.3389/fped.2020.00449. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2011
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): December 16, 2016

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lacrimal Apparatus Diseases; Premature Birth; Lacrimal Duct Obstruction
• Other Study ID Numbers: 2010DR4186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No