Evaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15% (NCT06189456) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15%
Italy100 participantsStarted 2023-06-21
Plain-language summary
This is a profit, multicentric, prospective, open-label, non-pharmacological clinical investigation aim to evaluate the efficacy and tollerability of two types of eye drops containing Hyaluronic acid (HA) with different concentration as 0.30% (BLUgel A) and 0.15% (BLUyal A). the study will consider patients affected by moderate to severe dry eye syndrome which will be treated with HA 0.30% while patients affected by mild dry eye syndrome will be treated with HA 0.15%.Dry eye syndrome (DES) is defined as a multifactorial disease of the ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface.Based on the available background on the use of HA in the management of DES, this investigation has been designed to assess the efficacy of HA- and amino acid-based product BLUgel A free and BLUyal A free, in patients with moderate to severe and mild dry eye syndrome, respectively.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients having signed written informed consent to participate in the investigation obtained according to Good Clinical Practice (GCP);
. Patients having an age ≥ 18 years;
. Patients with diagnosis of dry eye syndrome (according to Tear Film and Ocular Surface Society \[TFOS\] Dry Eye Workshop \[DEWS\] definition);
. Diagnosis of dry eye syndrome for the investigation assessed through at least the following exams: slit lamp examination (SLE), tear (lacrimal) meniscus exam, Schirmer's test I, TFBUT, cornea and conjunctiva staining, IDEEL questionnaire ("Dry Eye Symptom-Bother" module); 4a) Diagnosis of mild dry eye syndrome will be based on the following criteria:
. Patients being able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and patients able to cooperate with the Investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on Investigator's judgment;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing two different concentrations of hyaluronic acid eye drops — 0.30% and 0.15% — for dry eye syndrome. Given my specific symptoms and severity, which concentration might be more relevant to my situation, and is this worth discussing as an option?
2The trial's recruitment status is listed as 'unknown,' which could mean it's no longer actively enrolling. Can you help me find out whether this study is still open and accepting participants before I get my hopes up about joining?
3One of the main things this trial is measuring is something called Tear Film Break-Up Time — how would my doctor assess whether my dry eye is the type that would even show meaningful improvement on that kind of measure?
4Since this trial is classified as 'Phase NA,' meaning it may not fit the traditional drug trial phases, what does that tell us about how much safety and effectiveness data already exists for these hyaluronic acid drops, compared to products already available over the counter?
5Are there already approved or widely used hyaluronic acid eye drops for dry eye syndrome that I could try now, and how would those compare to what's being studied in this trial so I can weigh my options with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy Assessment from baseline
Timeframe: Day 30
2
Changes in Tear Film Break-Up Time (TFBUT) from baseline
. Female patients having a negative urine pregnancy test result at screening and using an appropriate method of contraception for at least 30 days before inclusion and during the whole investigation period, according to the definition of Note 3 of ICH M3 Guideline\*, if females of childbearing potential (i.e., not permanently sterilized - post hysterectomy or tubal ligation status - or not postmenopausal);
Exclusion criteria
. Patients with mild dry eye syndrome that have used eye drops product in the 15 days preceding the screening/baseline visit.
. Patients under treatment with corticosteroids or antibiotics eye drops, hypotony-inducing products or any other therapy that, as per Investigator's opinion, could interfere with the assessment of the efficacy or incidence of adverse events;
. Patients with presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that, according to Investigator's judgment, can interfere with the conduct of the required investigation procedures or the assessment of the efficacy or the interpretation of the investigation results or the incidence of adverse events;
. Patients with glaucoma;
. Patients that use therapeutic or refractive contact lenses;
. Patients with hypersensitivity and/or allergy to any of the BLUgel A free or BLUyal A free ingredients;
. History of ocular surgery in either eye, excluding corneal refractive or cataract procedures, within 90 days of investigation enrolment;
. Patients not being able to apply during the investigation any eye drops product;