RecruitingNot ApplicableNCT05865457

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


Sponsor

TRB Chemedica International SA

Enrollment

80 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BUFY02 eye drops in single-dose containers and a medical device called TRB02 eye drops in single-dose containers for people with dry-eye disease. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBUFY02 eye drops in single-dose containers

1 to 2 drops in each eye, as often as needed

DEVICETRB02 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

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NCT05865457


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