NCT05865457

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: TRB Chemedica International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	BUFY02 eye drops in single-dose containers	1 to 2 drops in each eye, as often as needed
DEVICE	TRB02 eye drops in single-dose containers	1 to 2 drops in each eye, as often as needed

Timeline

• Start date: 2025-09-25
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2023-05-18
• Last updated: 2026-02-05

Locations

5 sites across 2 countries: Austria, France