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

NCT04122300 | Completed Phase 3

• 1 other identifier: 2010DR4186
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenita Nasolacrimal Duct Obstruction; Preterm Neonates; Ocular Discharge

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Euphrasia arm

EXPERIMENTAL

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

Placebo arm

PLACEBO COMPARATOR

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

Interventions

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).

Euphrasia arm

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).

Placebo arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Neonatology, Children University Hospital of Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32850558 DERIVED

Study Officials

• Ursula Wolf

  Institute for complementary and integrative medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: May 22, 2011
• Primary Completion: December 12, 2016
• Study Completion: December 16, 2016
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)