Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct (Euphrasia)
Primary Purpose
Congenita Nasolacrimal Duct Obstruction, Preterm Neonates, Ocular Discharge
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Euphrasia Officinalis Preparation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Congenita Nasolacrimal Duct Obstruction
Eligibility Criteria
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)
Sites / Locations
- Department of Neonatology, Children University Hospital of Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Euphrasia arm
Placebo arm
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04122300
Brief Title
Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct
Acronym
Euphrasia
Official Title
Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct - a Randomized Double-blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 22, 2011 (Actual)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
December 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenita Nasolacrimal Duct Obstruction, Preterm Neonates, Ocular Discharge
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Euphrasia arm
Arm Type
Experimental
Arm 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.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Euphrasia Officinalis Preparation
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Number of patients with treatment success at 96 hours
Description
Treatment success is defined as no ocular discharge at 96 hours and no use of topical antibiotic therapy during the 96-hour intervention period
Time Frame
96 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Wolf
Organizational Affiliation
Institute for complementary and integrative medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neonatology, Children University Hospital of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32850558
Citation
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.
Results Reference
derived
Learn more about this trial
Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct
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