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COMPLETED
NCT06189456
NA

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

Sponsor: Fidia Farmaceutici s.p.a.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

101

Start Date

2023-06-21

Completion Date

2024-12-04

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

DEVICE

BLUgel A

BLUgel A: Hyaluronic Acid Eye Drops 0.30%

DEVICE

BLUyal A

BLUyal A:Hyaluronic Acid Eye Drops 0.15%

Locations (3)

Azienda Ospedaliera Universitaria-Renato Dulbecco

Catanzaro, CZ, Italy

AOU Careggi

Florence, Firenze, Italy

ASST Santi Paolo e Carlo P.O San Paolo

Milan, Milano, Italy