Can hyaluronic acid eye drops soothe dry, irritated eyes?
NCT ID NCT06189456
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing two eye drops that contain hyaluronic acid and amino acids in people with dry eye syndrome. Adults with moderate to severe dry eye receive the 0.30% drop, while those with mild dry eye receive the 0.15% drop. The study measures changes in eye surface staining and tear film stability over 30 to 60 days to see whether the drops improve eye comfort and health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hyaluronic acid eye drops with amino acids
- What this could lead to
- If the drops work, they could offer a simple way to ease dry eye discomfort and protect the eye surface for people with mild to severe symptoms.
- What could go wrong
- This is an open-label study with no placebo group, so improvements may partly reflect expectation. Results may not apply to other dry eye products or to people with different causes of dry eye.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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101 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients who meet all the following criteria at the screening/baseline visit will be considered as eligible for the investigation: 1. Patients having signed written informed consent to participate in the investigation obtained according to Good Clinical Practice (GCP); 2. Patients having an age ≥ 18 years; 3. Patients with diagnosis of dry eye syndrome (according to Tear Film and Ocular Surface Society \[TFOS\] Dry Eye Workshop \[DEWS\] definition); 4. 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: * TFBUT 7-10 sec * Schirmer's test I 7-10 mm * Fluorescein staining of the cornea and conjunctiva (NEI scale value) \<7 * IDEEL questionnaire ("Dry Eye Symptom-Bother" module) score 40-50 * Patient not treated in the previous 15 days for dry eye syndrome 4b) Diagnosis of moderate to severe dry eye syndrome will be based on the following criteria: * TFBUT \< 7 sec * Schirmer's test I \< 7 mm * Fluorescein staining of the cornea and conjunctiva (NEI scale value) ≥7 * IDEEL questionnaire ("Dry Eye Symptom-Bother" module) score \>50 * Dry eye syndrome treatment permitted; no ophthalmic gel treatment permitted In case of bilateral dry eye syndrome, both eyes will be treated but only the worst eye, defined as the eye with the higher severity of impairment according to the Investigator's judgment based on the above exams, will be considered for assessments (although both eyes will be treated). In the case of bilateral dry eye syndrome with both eyes having the same level of impairment, the right eye will be considered for assessments by convention; In case of monolateral dry eye syndrome, both eyes will be treated. Evaluations of both the eyes will be collected but only target eye evaluations will be used for statistical analysis. 5. 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; 6. 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); * Note: According to the definition of Note 3 of ICH M3 Guideline a highly effective method is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence. Exclusion Criteria: Patients who fulfil any of the following criteria at the screening/baseline visit will be excluded from the investigation: 1. Patients with mild dry eye syndrome that have used eye drops product in the 15 days preceding the screening/baseline visit. Patients with moderate to severe dry eye syndrome may have used treatment for dry eye syndrome in the 15 days preceding the screening/baseline visit, with the exception of gel compounds; 2. 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; 3. 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; 4. Patients with glaucoma; 5. Patients that use therapeutic or refractive contact lenses; 6. Patients with hypersensitivity and/or allergy to any of the BLUgel A free or BLUyal A free ingredients; 7. History of ocular surgery in either eye, excluding corneal refractive or cataract procedures, within 90 days of investigation enrolment; 8. Patients not being able to apply during the investigation any eye drops product; 9. Patients treated with antidepressant, antiepileptic, antihistamine, anticholinergic drug; 10. Patients participating to another clinical study/investigation at the same time as the present investigation or within 30 days; 11. Patients who have history of drug, medication or alcohol abuse or addiction
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AOU Careggi
Florence, Firenze, 50134, Italy
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ASST Santi Paolo e Carlo P.O San Paolo
Milan, Milano, 20142, Italy
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Azienda Ospedaliera Universitaria-Renato Dulbecco
Catanzaro, CZ, 88100, Italy
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