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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyedrops treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid eye drops | Device | Hyaluronic acid (HA)-based eyedrops |
|
| Measure | Description | 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Policlinico "G.Rodolico - San Marco" | Catania | CT | 95123 | Italy |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 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) |