Ocular DischargeNCT05855486
PMCF Study to Evaluate Performance and Safety of "LUXIDROPIN BABY & JUNIOR"
A study testing Saline eye drops in people with Ocular Discharge, run by C.O.C. Farmaceutici S.r.l. at 1 site in Italy.
Trial summary
Children's tear film and ocular surface are increasingly exposed to environmental factors. The tear film is the most important barrier protecting the eye from external insults such as pollen, dust, sand. Read more about this study
- Who is it for?
- Ages 10 days to 11 years
- Conditions the study is for
- Ocular Discharge
- What is being tested?
- Saline eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2022to 23 Mar 2023
- Phase
- Interventional
- 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 10 days to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric subjects whose ICF will be signed by parent(s) or legal guardian;
- M \& F newborns (10-27 days), infants (28 days-23 months), children (2-11 years);
- Ocular discharge (pediatric subjects presenting with ocular secretions due nasolacrimal duct obstruction; pediatric subjects presenting with amblyopia, redness of the ocular mucosa, burning, itching due to climatic factors or seasonal allergies).
- Willingness not to use other ophthalmic solutions (spray or drops) during the entire study.
Who cannot join
- Preterm newborns;
- Pediatric subjects with congenital abnormalities of the eye, physical trauma, corneal infiltrate or ulcers in either eye. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values;
- Pediatric subjects with/without eye infections requiring treatment with topical or systemic antibiotics;
- Previous eye surgery;
- Suspected other - different - eyes clinical conditions (e.g. glaucoma);
- Suspected known hypersensitivity or allergy to Investigational Product (IP) components;
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- Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. diabetes);
- Participation in another investigational study;
- Parent(s)' and/or patients' inability to follow all study procedures, including attending all site visits, tests and evaluations;
- Parent(s)' and/or patients' mental incapacity that precludes adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Policlinico Mater Domini - Università Magna Grecia di Catanzaro
Catanzaro, CZ, 88100
About this study
Official title: An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "LUXIDROPIN BABY & JUNIOR" Used to Facilitate the Removal of Ocular Secretions in Pediatric Subjects
Children's tear film and ocular surface are increasingly exposed to environmental factors. The tear film is the most important barrier protecting the eye from external insults such as pollen, dust, sand. If a foreign substance is not washed away by the tear film, it eventually reaches the ocular surface resulting in eye irritation, ocular secretions, and/or allergic response. Primary intervention is aimed at avoiding allergens and using eye lubricants to facilitate the washout of the foreign substance. It is also recommended to regularly clean the children's eyes to avoid infections. Topical medications are usually recommended only in the presence of infectious conjunctivitis.
Ocular secretions are also commonly observed in newborn babies. Neonatal ocular discharge is often related to congenital nasolacrimal duct obstruction (CNLDO) which normally occurs within the first weeks of age. CNLDO (also known as dacryostenosis) results from a congenital abnormality of the lacrimal drainage system in the form of a membranous obstruction of the nasolacrimal duct of one or both eyes. In most cases, blocked tear ducts open spontaneously within the first 6-12 months of age. Traditionally, management of CNLDO consists of frequent lacrimal sac massages and regular cleaning of the eyes. Topical antibiotic therapy is indicated only with the clinical evidence of infection.
Read more
For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "LUXIDROPIN BABY \& JUNIOR" used to facilitate the removal of ocular secretions in pediatric subjects.
The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with the use of "LUXIDROPIN BABY \& JUNIOR" according to the Instructions for Use (IFU).
Each pediatric subject whose parent(s)/legal guardian signed an Informed Consent Form (ICF), will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.
At baseline visit (V0), "LUXIDROPIN BABY \& JUNIOR" will be administered to the enrolled subject.
The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.
- Conditions
- Ocular Discharge
- Being tested
- Saline eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline eye dropsDevice
Ocular drops used to facilitate the removal of ocular secretions in pediatric subjects
| Study group | Role | What they receive |
|---|---|---|
| Eyedrops treatment arm | Experimental | Not described Receives: Device: Saline eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with clinical resolution, measured as the absence of ocular secretions, will be assessed at the end of the study visit (Day 4).
Measured: From baseline (Day 0) to 4 days (Day 4 (96h))
Secondary outcomes (4)
To evaluate the performance of "LUXIDROPIN BABY & JUNIOR" to relieve redness of the ocular mucosa and itching, through Visual Analogue Scale (VAS( for assessment of ocular discomfort
Visual Analogue Scale:
Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
Measured: From baseline (Day 0) to 4 days (Day 4 (96h))
To evaluate the safety and tolerability of "LUXIDROPIN BABY & JUNIOR" through eye examination and assessment of AEs including the relationship of the AE to the IP (e.g. local allergic reaction)
Measured: From baseline (Day 0) to 2 days (Day 2 (48 h)) and 4 days (Day 4 (96h))
To evaluate the capability of "LUXIDROPIN BABY & JUNIOR" to improve the quality of life (QoL), through Visual Analogue Scale (VAS) for assessment of the QoL
Visual Analogue Scale:
Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome
Measured: End of study visit (Day 4 (96h))
To evaluate the parent(s) or children's satisfaction through a Rensis Likert 5 points patients satisfaction scale
Rensis Likert 5 points patients satisfaction scale Minimum value: Very dissatisfied Maximum value: Very satisfied Higher scores mean a better outcome.
Measured: End of study visit (Day 4 (96h))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start12 Oct 2022
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular DischargeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.O.C. Farmaceutici S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855486
- Sponsor's protocol ID
- COC-R7-BABY
- Status last verified
- May 2023
- First submitted
- 13 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "LUXIDROPIN BABY & JUNIOR" Used to Facilitate the Removal of Ocular Secretions in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT05855486
- Acronym / sponsor ID
- COC-R7-BABY
- Conditions
- Ocular Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- C.O.C. Farmaceutici S.r.l.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 11 May 2023 (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.
Children's tear film and ocular surface are increasingly exposed to environmental factors. The tear film is the most important barrier protecting the eye from external insults such as pollen, dust, sand. If a foreign substance is not washed away by the tear film, it eventually reaches the ocular surface resulting in eye irritation, ocular secretions, and/or allergic response. Primary intervention is aimed at avoiding allergens and using eye lubricants to facilitate the washout of the foreign substance. It is also recommended to regularly clean the children's eyes to avoid infections. Topical medications are usually recommended only in the presence of infectious conjunctivitis.
Ocular secretions are also commonly observed in newborn babies. Neonatal ocular discharge is often related to congenital nasolacrimal duct obstruction (CNLDO) which normally occurs within the first weeks of age. CNLDO (also known as dacryostenosis) results from a congenital abnormality of the lacrimal drainage system in the form of a membranous obstruction of the nasolacrimal duct of one or both eyes. In most cases, blocked tear ducts open spontaneously within the first 6-12 months of age. Traditionally, management of CNLDO consists of frequent lacrimal sac massages and regular cleaning of the eyes. Topical antibiotic therapy is indicated only with the clinical evidence of infection.
For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "LUXIDROPIN BABY \& JUNIOR" used to facilitate the removal of ocular secretions in pediatric subjects.
The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with the use of "LUXIDROPIN BABY \& JUNIOR" according to the Instructions for Use (IFU).
Each pediatric subject whose parent(s)/legal guardian signed an Informed Consent Form (ICF), will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.
At baseline visit (V0), "LUXIDROPIN BABY \& JUNIOR" will be administered to the enrolled subject.
The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eyedrops treatment arm | Experimental | Device: Saline eye drops |
Who may qualify
- Ages
- 10 days to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric subjects whose ICF will be signed by parent(s) or legal guardian;
- M \& F newborns (10-27 days), infants (28 days-23 months), children (2-11 years);
- Ocular discharge (pediatric subjects presenting with ocular secretions due nasolacrimal duct obstruction; pediatric subjects presenting with amblyopia, redness of the ocular mucosa, burning, itching due to climatic factors or seasonal allergies).
- Willingness not to use other ophthalmic solutions (spray or drops) during the entire study.
Key exclusion criteria (10 listed)
- Preterm newborns;
- Pediatric subjects with congenital abnormalities of the eye, physical trauma, corneal infiltrate or ulcers in either eye. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values;
- Pediatric subjects with/without eye infections requiring treatment with topical or systemic antibiotics;
- Previous eye surgery;
- Suspected other - different - eyes clinical conditions (e.g. glaucoma);
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 |
|---|---|---|
| Saline eye dropsOcular drops used to facilitate the removal of ocular secretions in pediatric subjects | Device | Eyedrops treatment arm |
Primary outcome
Proportion of patients with clinical resolution, measured as the absence of ocular secretions, will be assessed at the end of the study visit (Day 4).
Time frame: From baseline (Day 0) to 4 days (Day 4 (96h))
4 secondary outcomes
To evaluate the performance of "LUXIDROPIN BABY & JUNIOR" to relieve redness of the ocular mucosa and itching, through Visual Analogue Scale (VAS( for assessment of ocular discomfort
Time frame: From baseline (Day 0) to 4 days (Day 4 (96h))
To evaluate the safety and tolerability of "LUXIDROPIN BABY & JUNIOR" through eye examination and assessment of AEs including the relationship of the AE to the IP (e.g. local allergic reaction)
Time frame: From baseline (Day 0) to 2 days (Day 2 (48 h)) and 4 days (Day 4 (96h))
To evaluate the capability of "LUXIDROPIN BABY & JUNIOR" to improve the quality of life (QoL), through Visual Analogue Scale (VAS) for assessment of the QoL
Time frame: End of study visit (Day 4 (96h))
To evaluate the parent(s) or children's satisfaction through a Rensis Likert 5 points patients satisfaction scale
Time frame: End of study visit (Day 4 (96h))
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 11 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline eye drops in people with Ocular Discharge, run by C.O.C. Farmaceutici S.r.l. at 1 site in Italy.
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 4 inclusion and 10 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 11 May 2023. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Proportion of patients with clinical resolution, measured as the absence of ocular secretions, will be assessed at the end of the study visit (Day 4). (time frame: From baseline (Day 0) to 4 days (Day 4 (96h))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.