Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823961
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2023-04-11
Brief Title:
PMCF Study to Evaluate Performance and Safety of CLHA-based Eyedrops Used to Improve Lacrimal Abnormalities
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 Cross-Linked Hyaluronic Acid CLHA-Based Eyedrops Used to Improve Lacrimal Abnormalities Even When Associated With 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:
Tear dysfunction also known as Dry Eye Disease DED is frequently encountered in the clinical practice It is a multifactorial disease of the ocular surface characterized by insufficient tear production loss of homeostasis of the tear film increased osmotic stress of the ocular surface ocular discomfort and visual disturbance
Hyaluronic acid HA is a linear heteropolysaccharide glycosaminoglycan with unique hygroscopic rheological and lubricating properties HA is naturally found at the human ocular surface where it contributes to the ocular hydration and lubrication thanks to its capability to bind water moleculesSodium hyaluronate SH the salt form of HA is widely used in artificial tears to counteract dry eye symptoms by facilitating eyelid sliding and reducing its friction on the corneal-conjunctival surface
Conventional HA-based eye drops contain linear HA However artificially cross-linked HA CLHA has several advantages over linear HA in alleviating dry eye symptoms The increased viscoelasticity of CLHA results in a greater stability and a better resistance to the enzymatic degradation by hyaluronidase while preserving all the properties of linear HA Furthermore chemical cross-linking of HA extends its permanence on the ocular surface thus reducing the number of instillations and increasing patients compliance
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 Cross-Linked Hyaluronic Acid CLHA-based eyedrops used as intended to improve lacrimal abnormalities even when associated with 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 Cross-Linked Hyaluronic Acid CLHA-based eyedrops according to the Instructions for Use IFU
Each subject after signing the 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 one of the CLHA-based eyedrops products 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
Hyaluronic acid HA is a linear heteropolysaccharide glycosaminoglycan with unique hygroscopic rheological and lubricating properties HA is naturally found at the human ocular surface where it contributes to the ocular hydration and lubrication thanks to its capability to bind water moleculesSodium hyaluronate SH the salt form of HA is widely used in artificial tears to counteract dry eye symptoms by facilitating eyelid sliding and reducing its friction on the corneal-conjunctival surface
Conventional HA-based eye drops contain linear HA However artificially cross-linked HA CLHA has several advantages over linear HA in alleviating dry eye symptoms The increased viscoelasticity of CLHA results in a greater stability and a better resistance to the enzymatic degradation by hyaluronidase while preserving all the properties of linear HA Furthermore chemical cross-linking of HA extends its permanence on the ocular surface thus reducing the number of instillations and increasing patients compliance
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 Cross-Linked Hyaluronic Acid CLHA-based eyedrops used as intended to improve lacrimal abnormalities even when associated with 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 Cross-Linked Hyaluronic Acid CLHA-based eyedrops according to the Instructions for Use IFU
Each subject after signing the 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 one of the CLHA-based eyedrops products 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