Evaluation of eye drops with different concentrations of hyaluronic acid for dry eye syndrome

Evaluation of the Efficacy and Safety of Eye Drops With Hyaluronic Acid Sodium Salt 0.30% and Amino Acid (BLUgel A Free) in Patients With Moderate to Severe Dry Eye Syndrome and Hyaluronic Acid Sodium Salt 0.15% and Amino Acid (BLUyal A Free) in Patients With Mild Dry Eye Syndrome

This study is testing two different strengths of eye drops with hyaluronic acid to see which one helps people with mild to severe dry eye syndrome feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fidia Farmaceutici s.p.a. (Industry-sponsored)
• Locations: 3 sites (Catanzaro, CZ and 2 other locations)
• Trial ID: NCT06189456 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to evaluate the efficacy and tolerability of two types of eye drops containing hyaluronic acid at concentrations of 0.30% and 0.15% for patients with varying severity of dry eye syndrome. Patients diagnosed with moderate to severe dry eye syndrome will receive the 0.30% formulation, while those with mild dry eye syndrome will be treated with the 0.15% formulation. The study will involve an initial screening followed by a 60-day treatment period with scheduled follow-up visits to assess outcomes. A total of 100 patients are expected to be enrolled across multiple centers.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with either mild or moderate to severe dry eye syndrome.

Not a fit: Patients with conditions unrelated to dry eye syndrome or those who do not meet the specific diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for patients suffering from dry eye syndrome, improving their quality of life.

How similar studies have performed: Other studies have shown promising results with hyaluronic acid in managing dry eye syndrome, indicating that this approach is supported by previous research.

Eligibility criteria

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

Where this trial is running

Catanzaro, CZ and 2 other locations

• Azienda Ospedaliera Universitaria-Renato Dulbecco — Catanzaro, Cz, Italy (Recruiting)
• AOU Careggi — Firenze, Italy (Recruiting)
• ASST Santi Paolo e Carlo P.O San Paolo — Milano, Italy (Recruiting)

Study contacts

• Principal investigator: Rita Mencucci, MD — AOU Careggi
• Study coordinator: Nicola Giordan

Conditions Dry Eye Syndrome