PMCF Study to Evaluate Performance and Safety of "Xanoftal Next"

NCT ID: NCT05829499

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2023-02-06

Brief Summary

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression.

Traditionally, dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases. However, recent literature has shown both conditions share similar characteristics, including several of their signs and symptoms (e.g. red, itchy, watery, and burning eyes).

On the other hand, red swollen eyelids, burning sensations, ocular irritation, loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis, an inflammatory disorder of eyelids affecting all the age and ethnic groups.

First-line therapy for treating dry eye symptoms consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration.

For these reasons, an interventional, non-comparative, Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Xanoftal Next" used to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome.

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 "Xanoftal Next" 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, the "Xanoftal Next" product will be administered 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

HPMC-HA eyedrops

Intervention Type: DEVICE

Ocular drops based upon HPMC and HA

Interventions

HPMC-HA eyedrops

Ocular drops based upon HPMC and HA

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Signed patient Informed consent form (ICF);
• Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
• Patients with ophthalmic discomfort due eye allergy or other eye discomfort caused by environmental or mechanical stress (e.g. use of computer and/or smartphone), including contact lenses wearing and blepharitis;
• Willing not to use other eye drops during the entire treatment period.

Exclusion Criteria

• Other - different - eyes clinical conditions (e.g. glaucoma);
• Known hypersensitivity or allergy to Investigational Product (IP) components;
• Suspected alcohol or drug abuse;
• Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases, 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-R9-HPMC-HA

Identifier Type: -

Identifier Source: org_study_id