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

NCT ID: NCT05825586

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2023-01-27

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 eye's 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, and/or 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 V2/EOS). 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 (e.g. type of eye-tear film, anatomy, age), their lifestyle (e.g. use of computer, wearing of contact lenses).

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

Distilled waters based eye drops

Intervention Type: DEVICE

Distilled Waters (DW)-based eyedrops

Interventions

Distilled waters based eye drops

Distilled Waters (DW)-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 ICF;
• Patients with ophthalmic discomfort due to atmospheric agents and/or environmental factors, contact lenses wearing or 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 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-R2-DW

Identifier Type: -

Identifier Source: org_study_id