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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye Syndrome (DES)
- Sponsor
- Fidia Farmaceutici s.p.a.
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Efficacy Assessment from baseline
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
This is a profit, multicentric, prospective, open-label, non-pharmacological clinical investigation. Patients will have an initial screening/baseline Visit 1-T0 (day 0). 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), while 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). The following on-site visits will be performed: Visit 2-T1 (day 15 \[+3\]), Visit 3-T2 (day 30 \[+3\]) and Visit 4-T3 (day 60 \[+3\]). Visit 3-T2 and Visit 4-T3 should be performed preferably at day 30 and day 60 respectively. In case Visit 3-T2 is postponed within the allowed window, treatment has to be continued by the patient without interruption. A total of 100 male or female patients who have been diagnosed with mild or moderate to severe dry eye syndrome are planned to be enrolled. Dry eye syndrome will be classified according to Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS) (2007 version) definition. Patients with diagnosis of moderate to severe dry eye syndrome will be treated with BLUgel A free for 60 days, patients with diagnosis of mild dry eye syndrome will be treated BLUyal A free for 60 days. Patients will be stratified in the two categories of severity, i.e. 50 patients with moderate/severe dry eye syndrome treated with BLUgel A free and 50 patients with mild dry eye syndrome treated with BLUyal A free. Patients are not permitted to use a concomitant drug or device interfering with the dryness of the eye, such as corticosteroid and antibiotic eye drops; instead, they are permitted to use any drug or device non-interfering with the treatment of dry eye syndrome and not affecting the effectiveness of BLUgel A free or BLUyal A free or the occurrence of adverse reactions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Efficacy Assessment from baseline
Time Frame: Day 30
-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;
Changes in Tear Film Break-Up Time (TFBUT) from baseline
Time Frame: Day 30
- 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.
Secondary Outcomes
- Efficacy Assessment from baseline in patients with moderate to severe dry eye syndrome(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 possible changes in meibomian gland from baseline(Day 30 and Day 60)
- Assessment of Tear meniscus height after treatment compared to baseline(Day 30 and Day 60)
- Assessment of conjunctival hypaermia from baseline(Day 30 and Day 60)
- Assessment of total tear secretion from baseline(Day 30 and Day 60)
- Assessment of impact of Dry Eye on Everyday Life (IDEEL) from baseline(Day 30 and Day 60)
- Incidence and nature of treatment-emergent adverse events(Day 30 and Day 60)