PMCF Study to Evaluate Performance and Safety of "Optrex Double Action Soothing and Lubricating Drops"

NCT ID: NCT05824000

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2022-08-05

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 V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

Conditions

Allergic Conjunctivitis; Dry Eye; Dry Eye Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eyedrops treatment arm

Group Type: EXPERIMENTAL

Eye drops for itchy and water eyes

Intervention Type: DEVICE

Ocular drops for itchy and watery eyes

Interventions

Eye drops for itchy and water eyes

Ocular drops for itchy and watery eyes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient Informed consent form (ICF) signed;
• Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
• Patients with ocular conditions typically associated with itchy and watery eyes (e.g. allergic conjunctivitis, dry eye disease);
• Willing not to use other eye drops during the entire treatment period.

Exclusion Criteria

• Other - different - eyes clinical conditions (e.g. glaucoma);
• Suspected alcohol or drug abuse.
• Known hypersensitivity or allergy to Investigational Product (IP) components;
• Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic disease, diabetes);
• Participation in another investigational study;
• Inability to follow all study procedures, including attending all site visits, tests and examinations;
• Mental incapacity that precludes adequate understanding or cooperation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C.O.C. Farmaceutici S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda Ospedaliera Policlinico Mater Domini - Università Magna Grecia di Catanzaro

Catanzaro, CZ, Italy

Countries

Italy

Other Identifiers

COC-R6-CBM

Identifier Type: -

Identifier Source: org_study_id