An interventional study of Saline eye drops in Ocular Discharge, sponsored by C.O.C. Farmaceutici S.r.l.. Completed at 1 site in Italy. Open to participants aged 10 Days to 11 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by C.O.C. Farmaceutici S.r.l. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device: Saline eye drops
Ocular drops used to facilitate the removal of ocular secretions in pediatric subjects
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))
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.
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
Visual Analogue Scale: Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome
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
Rensis Likert 5 points patients satisfaction scale Minimum value: Very dissatisfied Maximum value: Very satisfied Higher scores mean a better outcome.
Time frame: End of study visit (Day 4 (96h))
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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C.O.C. Farmaceutici S.r.l.