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

Not Applicable

Recruiting

• Conditions: Dry Eye Disease

• Registration Number: NCT05865457
• Lead Sponsor: TRB Chemedica International SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-06
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Signs	Day 28	Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)

Secondary Outcome Measures

Name	Time	Method
Symptoms	Day 28	Change from baseline in Ocular Surface Disease Index

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France