Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824000
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-11
Brief Title:
PMCF Study to Evaluate Performance and Safety of Optrex Double Action Soothing and Lubricating Drops
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 Optrex Double Action Soothing and Lubricating Drops
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:
Allergic conjunctivitis or ocular allergy and dry eye disease DED are two major ocular surface disorders affecting millions of people A typical clinical symptom of allergic conjunctivitis is itching which is also observed in subjects suffering from DED Common symptoms of DED also include a foreign body sensation dryness irritation burning sensation and visual disturbance Patients with allergic conjunctivitis or moderate-to-severe DED may experience a reduced quality of life due to ocular pain difficulty in performing daily activities and depression
Gel-based artificial tear supplements may offer longer retention times and act as a supplement to the mucin layer Carbomer also known as Carbopol polymers is awater-soluble polymeric resin that exhibit excellent viscoelastic and mucoadhesive properties when compared with other polymers Carbomer is used in liquid or semisolid pharmaceutical cosmetics and ophthalmic formulations as rheology modifiers Aqueous carbomer gels have been used for the treatment of dry eye and allergic conjunctivitis as they provide prolonged ocular residence time of conventional ophthalmic solutions Furthermore carbomer has shown compatibility with many active ingredients good thermal stability excellent organoleptic characteristics and good patient acceptance
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 Optrex Double Action soothing and lubricating drops for itchy and watery eyes
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 the use of Optrex Double Action soothing and lubricating drops according to 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 Optrex Double Action soothing and lubricating drops will be prescribed 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
Gel-based artificial tear supplements may offer longer retention times and act as a supplement to the mucin layer Carbomer also known as Carbopol polymers is awater-soluble polymeric resin that exhibit excellent viscoelastic and mucoadhesive properties when compared with other polymers Carbomer is used in liquid or semisolid pharmaceutical cosmetics and ophthalmic formulations as rheology modifiers Aqueous carbomer gels have been used for the treatment of dry eye and allergic conjunctivitis as they provide prolonged ocular residence time of conventional ophthalmic solutions Furthermore carbomer has shown compatibility with many active ingredients good thermal stability excellent organoleptic characteristics and good patient acceptance
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 Optrex Double Action soothing and lubricating drops for itchy and watery eyes
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 the use of Optrex Double Action soothing and lubricating drops according to 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 Optrex Double Action soothing and lubricating drops will be prescribed 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