Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825599
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2023-04-11
Brief Title:
PMCF Study to Evaluate Performance and Safety of HPMC-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 Hydroxypropyl Methylcellulose HPMC-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
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
Hydroxypropyl methylcellulose HPMC or hypromellose is a synthetic modification of the natural polymer cellulose It has been widely used in in ophthalmologic formulations such as eye drops and gels due to its solubility in water biocompatibility transparency and rheological properties Eye drops containing HPMC are conventionally used to treat tear film disturbances including dry eye symptoms
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 Hydroxypropyl methylcellulose HPMC-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 HPMC-based eyedrops according to the Instructions for Use IFU
HPMC-based eyedrops medical devices are ophthalmic solutions containing hydroxypropyl methylcellulose HPMC as key ingredient a polymer able to relief eye discomfort thanks to its moisturizing lubricating and muco-mimetic properties HPMC can stabilize the tear film on the ocular surface by creating a protective transparent and viscoelastic shield
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 only one of the below reported HPMC-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
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
Hydroxypropyl methylcellulose HPMC or hypromellose is a synthetic modification of the natural polymer cellulose It has been widely used in in ophthalmologic formulations such as eye drops and gels due to its solubility in water biocompatibility transparency and rheological properties Eye drops containing HPMC are conventionally used to treat tear film disturbances including dry eye symptoms
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 Hydroxypropyl methylcellulose HPMC-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 HPMC-based eyedrops according to the Instructions for Use IFU
HPMC-based eyedrops medical devices are ophthalmic solutions containing hydroxypropyl methylcellulose HPMC as key ingredient a polymer able to relief eye discomfort thanks to its moisturizing lubricating and muco-mimetic properties HPMC can stabilize the tear film on the ocular surface by creating a protective transparent and viscoelastic shield
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 only one of the below reported HPMC-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