Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825586
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2023-04-11
Brief Title:
PMCF Study to Evaluate Performance and Safety of Distilled Waters-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 Distilled Waters-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
Distilled waters of natural herbs such as Green Tea Calendula Chamomile Hamamelis and Euphrasia are known for their soothing and refreshing properties Thanks to the combined action of these natural elements distilled waters-based eyedrops are particularly indicated to relieve eye dryness irritation and redness of the eyes mucosa caused by atmospheric agents environmental factors andor use of contact lenses
Distilled waters-based eyedrops medical devices are ophthalmic solutions containing distilled waters able to relieve eye discomfort thanks to their soothing and refreshing action
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 Distilled waters-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 Distilled waters-based eyedrops according to the 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 Distilled waters-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
The first administration and the intervals at which the treatment should be repeated to be done as per Investigator judgment and according to 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
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
Distilled waters of natural herbs such as Green Tea Calendula Chamomile Hamamelis and Euphrasia are known for their soothing and refreshing properties Thanks to the combined action of these natural elements distilled waters-based eyedrops are particularly indicated to relieve eye dryness irritation and redness of the eyes mucosa caused by atmospheric agents environmental factors andor use of contact lenses
Distilled waters-based eyedrops medical devices are ophthalmic solutions containing distilled waters able to relieve eye discomfort thanks to their soothing and refreshing action
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 Distilled waters-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 Distilled waters-based eyedrops according to the 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 Distilled waters-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
The first administration and the intervals at which the treatment should be repeated to be done as per Investigator judgment and according to 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
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