Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-02 @ 6:21 AM
Study NCT ID:
NCT06189456
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2023-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15%
Sponsor:
Fidia Farmaceutici s.p.a.
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: