Congenita Nasolacrimal Duct ObstructionPhase 3EuphrasiaNCT04122300
Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct
A Phase 3 study testing Euphrasia Officinalis Preparation in people with Congenita Nasolacrimal Duct Obstruction and Preterm Neonates, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenita Nasolacrimal Duct Obstruction, Preterm Neonates, Ocular Discharge
- What is being tested?
- Euphrasia Officinalis Preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 May 2011to 16 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Congenital abnormalities of the eye
- Ophtalmia neonatorum
- Severe asphyxia
- Sepsis
- Intracranial bleeding (intraventricular hemorrhage ≥ grade III)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neonatology, Children University Hospital of Bern
Bern, 3010
About this study
Official title: 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.
- Being tested
- Euphrasia Officinalis Preparation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euphrasia Officinalis PreparationDrug
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).
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start22 May 2011
- Primary completion12 Dec 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenita Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ursula Wolf, Study chair, Institute for complementary and integrative medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122300
- Sponsor's protocol ID
- 2010DR4186
- Acronym
- Euphrasia
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32850558
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct - a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04122300
- Acronym / sponsor ID
- Euphrasia / 2010DR4186
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 22 May 2011 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euphrasia arm | Experimental | Drug: Euphrasia Officinalis PreparationEuphrasia 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 arm | Placebo comparator | Drug: PlaceboPlacebo (0.9% NaCl) is administrated at a dose of one drop in each eye four times a day over a period of 96 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Congenital abnormalities of the eye
- Ophtalmia neonatorum
- Severe asphyxia
- Sepsis
- Intracranial bleeding (intraventricular hemorrhage ≥ grade III)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Euphrasia Officinalis PreparationAt 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). | Drug | Euphrasia arm |
| PlaceboAt 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). | Drug | Placebo arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Derived from this study: PubMed 32850558Meier-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Wolf study chair
Institute for complementary and integrative medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Euphrasia Officinalis Preparation in people with Congenita Nasolacrimal Duct Obstruction and Preterm Neonates, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment success at 96 hours (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.