Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829499
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-13
Brief Title:
PMCF Study to Evaluate Performance and Safety of Xanoftal Next
Sponsor:
COC Farmaceutici Srl
Organization:
COC Farmaceutici Srl
Study Overview
Official Title:
Interventional Non-comparative Single-center PMCF Study to Evaluate Performance and Safety of Xanoftal Next Used to Attenuate Symptoms of Seasonal Allergic Conjunctivitis Even When Associated With Dry Eye Syndrome
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:
Dry eye disease DED also called keratoconjunctivitis sicca is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain difficulty in performing daily activities and depression
Traditionally dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases However recent literature has shown both conditions share similar characteristics including several of their signs and symptoms eg red itchy watery and burning eyes
On the other hand red swollen eyelids burning sensations ocular irritation loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis an inflammatory disorder of eyelids affecting all the age and ethnic groups
First-line therapy for treating dry eye symptoms consists of over the counter OTC artificial tear drops gels ointments or lubricants Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration
For these reasons an interventional non-comparative Post Marketing Clinical Follow-up PMCF study was planned to evaluate the performance and safety of Xanoftal Next used to attenuate symptoms of seasonal allergic conjunctivitis even when associated with dry eye syndrome
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 use of Xanoftal Next according to the Instructions for Use IFU
Each subject after signing the Informed Consent Form will enter the screening and baseline phase the 2 visits will coincide during which baseline procedures will be completed
At baseline visit the Xanoftal Next product 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
Traditionally dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases However recent literature has shown both conditions share similar characteristics including several of their signs and symptoms eg red itchy watery and burning eyes
On the other hand red swollen eyelids burning sensations ocular irritation loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis an inflammatory disorder of eyelids affecting all the age and ethnic groups
First-line therapy for treating dry eye symptoms consists of over the counter OTC artificial tear drops gels ointments or lubricants Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration
For these reasons an interventional non-comparative Post Marketing Clinical Follow-up PMCF study was planned to evaluate the performance and safety of Xanoftal Next used to attenuate symptoms of seasonal allergic conjunctivitis even when associated with dry eye syndrome
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 use of Xanoftal Next according to the Instructions for Use IFU
Each subject after signing the Informed Consent Form will enter the screening and baseline phase the 2 visits will coincide during which baseline procedures will be completed
At baseline visit the Xanoftal Next product 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