PMCF Study to Evaluate Performance and Safety of "Hyaluronic Acid (HA)-Based Eyedrops" Used to Relieve Dry Eye Symptoms

An Interventional, Non-comparative, Single-center Post Marketing Clinical Follow-up (PMCF) Study to Evaluate Performance and Safety of "Hyaluronic Acid (HA)-Based Eyedrops" Used to Relieve Dry Eye Symptoms.

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.

HA is found in higher concentrations in the vitreous humor of the eye, cartilage, and the synovial fluid. As a component of the tear film, HA increases the viscosity of the tear film and hydrates and lubricates the ocular surface. HA possesses intrinsic water retention properties, viscoelasticity, and favors the healing of corneal and conjunctival epithelium.

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 "HA-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 "HA-based eyedrops" according to the IFU.

"Hyaluronic Acid (HA)-based eyedrops" are medical devices used as intended to improve the discomfort due to dry eye (for intrinsic and/or extrinsic causes), contact lenses wearing and/or eye surgery.

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 "Hyaluronic Acid (HA)-based eyedrops" products can be dispensed to the enrolled Subjects, depending on Investigator clinical evaluation, and severity of the disease.

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 (AEs) and concomitant medications intake.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Disease; Kerato Conjunctivitis Sicca
• Intervention / Treatment: Device: Hyaluronic acid eye drops

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caterina MR Gagliano; Phone Number: +39 095 4794330; Email: caterina_gagliano@hotmail.com

Study Locations

• Italy
  • CT
    • Catania, CT, Italy, 95123
      • Azienda Ospedaliero-Universitaria Policlinico "G.Rodolico - San Marco"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient Informed consent form (ICF) signed;
• Male & Female Aged ≥ 18 years at the time of the signature of the ICF;
• Patients with ophthalmic discomfort due to dry eye for intrinsic and/or extrinsic causes, contact lenses wearing and/or eye surgery;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eyedrops treatment arm	Device: Hyaluronic acid eye drops; Hyaluronic acid (HA)-based eyedrops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Schirmer Test I: to evaluate the performance of the "HA-based eyedrops" used to relieve dry eye symptoms due to both intrinsic and extrinsic causes, through Schirmer I test	From Baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "HA-based eyedrops" used to relieve eye discomfort sensation		From Baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)
Change in Tear Break-up Time (TBUT): to evaluate the performance of the "HA-based eyedrops" used to relieve ophthalmic stress due to prolonged use of contact lenses or surface eye surgery, through the TBUT test		From Baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)
To evaluate the safety and tolerability of the "HA-based eyedrops" through Visual Analogical Scale (VAS) - evaluation of symptoms related to dry eye disease (burning, fatigue, discomfort, redness)	Visual Analogical Scale Minimum value = 0 Maximum value = 10 Higher scores mean a better outcome	End of study visit (EOS/V2 = Day 30)
To evaluate the patient satisfaction of the "HA-based eyedrops" through a 5-points Likert Scale		End of study visit (EOS/V2 = Day 30)

Collaborators and Investigators

• Sponsor: C.O.C. Farmaceutici S.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Conjunctivitis; Keratoconjunctivitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid
• Other Study ID Numbers: COC-R1-HA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No