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Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease
Sponsor: TRB Chemedica International SA
Summary
The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are: * Is BUFY02 non-inferior to TRB02 in terms of signs of DED? * Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED? Participants will be asked to: * Visit the trial site at 4 different timepoints * Use the allocated study treatment everyday until the end of the study (during 3 months) * Be examined by the investigator * Complete several questionnaires * Return unused study treatment. Researchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.
Official title: Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-09-25
Completion Date
2027-06
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
BUFY02 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
TRB02 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
Locations (5)
Medical University Graz
Graz, Austria
VIROS
Vienna, Austria
CHRU Brest
Brest, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU Nice
Nice, France