An interventional study of Cross-linked hyaluronic acid eye drops in Dry Eye Disease, Dry Eye 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
Tear dysfunction, also known as Dry Eye Disease (DED) is frequently encountered in the clinical practice. It is a multifactorial disease of the ocular surface characterized by insufficient tear production, loss of homeostasis of the tear film, increased osmotic stress of the ocular surface, ocular discomfort and visual disturbance.
Hyaluronic acid (HA) is a linear heteropolysaccharide (glycosaminoglycan) with unique hygroscopic, rheological, and lubricating properties. HA is naturally found at the human ocular surface where it contributes to the ocular hydration and lubrication thanks to its capability to bind water molecules.Sodium hyaluronate (SH), the salt form of HA, is widely used in artificial tears to counteract dry eye symptoms by facilitating eyelid sliding and reducing its friction on the corneal-conjunctival surface.
Conventional HA-based eye drops contain linear HA. However, artificially cross-linked HA (CLHA) has several advantages over linear HA in alleviating dry eye symptoms. The increased viscoelasticity of CLHA results in a greater stability and a better resistance to the enzymatic degradation by hyaluronidase, while preserving all the properties of linear HA. Furthermore, chemical cross-linking of HA extends its permanence on the ocular surface, thus reducing the number of instillations and increasing patients' compliance.
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 "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" used as intended to improve lacrimal abnormalities, even when associated with 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 "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" according to the Instructions for Use (IFU).
Each subject, after signing the Informed Consent Form (ICF), 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 "CLHA-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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 80 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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Exclusion Criteria:
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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.
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.
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.
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.
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.
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.
Device: Cross-linked hyaluronic acid eye drops
Cross-linked hyaluronic acid (CLHA)-based eyedrops
Change in Schirmer Test I: to evaluate the performance of the "CLHA-based eyedrops" used to improve lacrimal abnormalities, even when associated with dry eye symptoms due to intrinsic or extrinsic factors, through the Schirmer I test
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Change in Ocular Surface Disease Index (OSDI): to evaluate the performance of the "CLHA-based eyedrops" used to relieve discomfort to the eyes or ocular mucosa, and eye fatigue caused by intrinsic or extrinsic factors, through OSDI
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
Change in Tear Break-up Time (TBUT): to evaluate the performance of the "CLHA-based eyedrops" used to improve tear film stability in subjects with dry eye symptoms and/or after eye surgery, through the TBUT test
Time frame: From baseline (V0 = Day 0) to 1 month (EOS/V2 = Day 30 ± 2)
The global patient treatment tolerance to the "Cross-Linked Hyaluronic Acid (CLHA)-based eyedrops" as assessed by the Visual Analogue Scale (VAS) as a difference between baseline and Day 30.
Visual Analogue Scale: Minimum value = 0; Maximum value = 10; Higher scores mean a better outcome.
Time frame: End of study visit (EOS/V2 = Day 30 ± 2)
To evaluate the patient satisfaction through a Rensis Likert 5 points patient satisfaction scale
Rensis Likert 5 points patient satisfaction scale Minimum value: Very dissatisfied Maximum value: Very satisfied Higher scores mean a better outcome
Time frame: End of study visit (EOS/V2 = Day 30 ± 2)
Ran from Jun 2022 to primary completion in Jun 2023, 12 months.
Of 113 industry-sponsored interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 12 months is above that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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C.O.C. Farmaceutici S.r.l.