Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05855486
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2023-04-13
Brief Title:
PMCF Study to Evaluate Performance and Safety of LUXIDROPIN BABY JUNIOR
Sponsor:
COC Farmaceutici Srl
Organization:
COC Farmaceutici Srl
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Childrens 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 andor 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 childrens 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 parentslegal 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 V2EOS To monitor the safety 1 phone contact is planned V1 to check for potential adverse events and concomitant medications intake
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 parentslegal 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 V2EOS To monitor the safety 1 phone contact is planned V1 to check for potential adverse events and concomitant medications intake
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None