Evaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15%

NCT06189456 | Unknown

• 1 other identifier: IS01-21-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Dry Eye Syndrome (DES)

Outcome Measures

Primary Outcomes (2)

• Efficacy Assessment from baseline

  -Changes from baseline (T0) to Day 30 (T2) of overall score of National Eye Institute (NEI) corneal (range 0-15) and conjunctival (range 0-18) fluorescein staining, following treatment with BLUgel A free ophthalmic solution in patients with moderate to severe dry eye syndrome;

  Day 30

• Changes in Tear Film Break-Up Time (TFBUT) from baseline

  \- Changes from baseline (T0) to Day 30 (T2) in Tear Film Break-Up Time (TFBUT) values, following treatment with BLUyal A free ophthalmic solution in patients with mild dry eye syndrome. The TFBUT will be measured twice during the first minute after the instillation of the fluorescein. If the 2 readings differ by more than 2 seconds a third reading will be taken. The TFBUT value will be the average of the 2 or 3 measurements.

  Day 30

Secondary Outcomes (10)

• Efficacy Assessment from baseline in patients with moderate to severe dry eye syndrome

  Day 60

• Efficacy Assessment from baseline

  Day 30 and Day 60

• Efficacy Assessment from baseline

  Day 30 and Day 60

• Change in non-invasive Break-Up Time (niBUT) from baseline

  Day 30 and Day 60

• Assessment of Tear meniscus height after treatment compared to baseline

  Day 30 and Day 60

Study Arms (2)

Group A

EXPERIMENTAL

Patients with diagnosis of moderate to severe dry eye syndrome will start a 60 days treatment period with BLUgel A free (2 drops per eye, 3 times a day, bilaterally)

Device: BLUgel A

Group B

EXPERIMENTAL

Patients with diagnosis of mild dry eye syndrome will start a 60 days treatment period with BLUyal A free (2 drops per eye, 3 times a day, bilaterally).

Device: BLUyal A

Interventions

BLUgel A DEVICE

BLUgel A: Hyaluronic Acid Eye Drops 0.30%

Group A

BLUyal A DEVICE

BLUyal A:Hyaluronic Acid Eye Drops 0.15%

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all the following criteria at the screening/baseline visit will be considered as eligible for the investigation:
• 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:
• 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

You may not qualify if:

• Patients who fulfil any of the following criteria at the screening/baseline visit will be excluded from the investigation:
• 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;
• 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;
• Patients treated with antidepressant, antiepileptic, antihistamine, anticholinergic drug;
• Patients participating to another clinical study/investigation at the same time as the present investigation or within 30 days;
• Patients who have history of drug, medication or alcohol abuse or addiction

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (3)

Azienda Ospedaliera Universitaria-Renato Dulbecco

Catanzaro, CZ, 88100, Italy

RECRUITING

AOU Careggi

Florence, 50134, Italy

RECRUITING

ASST Santi Paolo e Carlo P.O San Paolo

Milan, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Rita Mencucci, MD

  AOU Careggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Giordan

CONTACT

+390498232512; ngriordan@fidiapharma.it

Michela Costantino

CONTACT

+390498232107; mcostantino@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: profit, multicentric, prospective, open-label, non-pharmacological clinical investigation

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 3, 2024
• Study Start: June 21, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)