PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms

NCT ID: NCT05825599

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-01-30

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

Conditions

Dry Eye; Dry Eye Disease; Kerato Conjunctivitis Sicca

Study Design

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

Study Groups

Eyedrops treatment arm

Group Type: EXPERIMENTAL

Hydroxypropyl methylcellulose eye drops

Intervention Type: DEVICE

Hydroxypropyl methylcellulose (HPMC)-based eyedrops

Interventions

Hydroxypropyl methylcellulose eye drops

Hydroxypropyl methylcellulose (HPMC)-based eyedrops

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 symptoms such as burning, itching, and foreign body sensation due to environmental factors, contact lenses wearing, and/or moderate-severe dry eye symptoms;
• 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 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-R3-HPMC

Identifier Type: -

Identifier Source: org_study_id