Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807360
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2023-03-13
Brief Title:
PMCF Study to Evaluate Performance and Safety of Hyaluronic Acid HA-Based Eyedrops 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 Hyaluronic Acid HA-Based Eyedrops Used to Relieve Dry Eye Symptoms
Status:
COMPLETED
Status Verified Date:
2023-04
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 common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface The typical symptoms of DED include irritation discomfort blurred or fluctuating vision
Over the counter OTC artificial tears are typically the first line of dry eye treatment they are meant to supplement the tears that cover the eyes surface OTC products mimic the different layers of the tear film in order to maintain ocular hydration
HA is found in higher concentrations in the vitreous humor of the eye cartilage and the synovial fluid As a component of the tear film HA increases the viscosity of the tear film and hydrates and lubricates the ocular surface HA possesses intrinsic water retention properties viscoelasticity and favors the healing of corneal and conjunctival epithelium
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 HA-based eyedrops 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 HA-based eyedrops according to the IFU
Hyaluronic Acid HA-based eyedrops are medical devices used as intended to improve the discomfort due to dry eye for intrinsic andor extrinsic causes contact lenses wearing andor eye surgery
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 Hyaluronic Acid HA-based eyedrops products can be dispensed to the enrolled Subjects depending on Investigator clinical evaluation and severity of the disease
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 AEs and concomitant medications intake
Over the counter OTC artificial tears are typically the first line of dry eye treatment they are meant to supplement the tears that cover the eyes surface OTC products mimic the different layers of the tear film in order to maintain ocular hydration
HA is found in higher concentrations in the vitreous humor of the eye cartilage and the synovial fluid As a component of the tear film HA increases the viscosity of the tear film and hydrates and lubricates the ocular surface HA possesses intrinsic water retention properties viscoelasticity and favors the healing of corneal and conjunctival epithelium
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 HA-based eyedrops 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 HA-based eyedrops according to the IFU
Hyaluronic Acid HA-based eyedrops are medical devices used as intended to improve the discomfort due to dry eye for intrinsic andor extrinsic causes contact lenses wearing andor eye surgery
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 Hyaluronic Acid HA-based eyedrops products can be dispensed to the enrolled Subjects depending on Investigator clinical evaluation and severity of the disease
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 AEs 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