An interventional study of Hyaluronic acid eye drops in Dry Eye, Dry Eye Disease and Kerato Conjunctivitis Sicca, sponsored by C.O.C. Farmaceutici S.r.l.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by C.O.C. Farmaceutici S.r.l. · Not applicable, Interventional, and Treatment
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →C.O.C. Farmaceutici S.r.l. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Hyaluronic acid eye drops
Hyaluronic acid (HA)-based eyedrops
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
Time frame: From Baseline (V0 = Day 0) at 1 month (EOS/V2 = Day 30)
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "HA-based eyedrops" used to relieve eye discomfort sensation
Time frame: 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
Time frame: 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
Time frame: End of study visit (EOS/V2 = Day 30)
To evaluate the patient satisfaction of the "HA-based eyedrops" through a 5-points Likert Scale
Time frame: End of study visit (EOS/V2 = Day 30)
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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C.O.C. Farmaceutici S.r.l.