NCT05807360

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

Completed NA Last updated 27 March 2024

What this trial tests

NA trial testing Hyaluronic acid eye drops in Dry Eye in 160 participants. Completed in 5 June 2023.

Timeline

24 June 2022

Primary endpoint
5 June 2023

5 June 2023

Quick facts

Lead sponsor	C.O.C. Farmaceutici S.r.l.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	160
Start date	24 June 2022
Primary completion	5 June 2023
Estimated completion	5 June 2023
Sites	1 location across Italy

Drugs / interventions tested

• Hyaluronic acid eye drops — full drug profile →

Conditions studied

• Dry Eye — all drugs for Dry Eye →
• Dry Eye Disease — all drugs for Dry Eye Disease →
• Kerato Conjunctivitis Sicca — all drugs for Kerato Conjunctivitis Sicca →

Sponsor

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

Who can join

18 and older, any sex, with Dry Eye or Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.