Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825352
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-11
Brief Title:
PMCF Study to Evaluate Performance and Safety of Ocular Drops Based Upon Carmellose Used to Relieve Dry Eye Symptoms
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 Ocular Drops Based Upon Carmellose Used to Relieve Dry Eye Symptoms
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
Tear Film Ocular Surface Society Dry Eye Workshop TFOS DEWS II recommends individualized management of DED based on the relative contribution of aqueous deficient and evaporative pathophysiology to the extent that this can be determined as well as disease severity
First-line for treating dry eye consists of over the counter OTC artificial tear drops gels ointments or lubricants
Carboxymethyl cellulose CMC is one of the most common viscous polymers used in artificial tears to achieve prolonged residence time on the ocular surface
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 Ocular drops based upon carmellose used as intended to relieve dry eye symptoms
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 Ocular drops based upon carmellose according 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 V0 one of the Ocular drops based upon carmellose products can be dispensed to the enrolled subject depending on Investigator clinical evaluation and decision
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
The first administration and the intervals at which the treatment should be repeated to be done as per Investigator judgment and according the IFU depend on various factors regarding the physiology of the patients eg type of eye-tear film anatomy age their lifestyle eg use of computer wearing of contact lenses and their eye-surgery history if applicable
Tear Film Ocular Surface Society Dry Eye Workshop TFOS DEWS II recommends individualized management of DED based on the relative contribution of aqueous deficient and evaporative pathophysiology to the extent that this can be determined as well as disease severity
First-line for treating dry eye consists of over the counter OTC artificial tear drops gels ointments or lubricants
Carboxymethyl cellulose CMC is one of the most common viscous polymers used in artificial tears to achieve prolonged residence time on the ocular surface
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 Ocular drops based upon carmellose used as intended to relieve dry eye symptoms
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 Ocular drops based upon carmellose according 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 V0 one of the Ocular drops based upon carmellose products can be dispensed to the enrolled subject depending on Investigator clinical evaluation and decision
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
The first administration and the intervals at which the treatment should be repeated to be done as per Investigator judgment and according the IFU depend on various factors regarding the physiology of the patients eg type of eye-tear film anatomy age their lifestyle eg use of computer wearing of contact lenses and their eye-surgery history if applicable
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