RecruitingNot ApplicableNCT05865379

Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease

Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation


Sponsor

TRB Chemedica International SA

Enrollment

80 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are: * Is BUFY01 non-inferior to SVS20 in terms of signs of DED? * Is BUFY01 non-inferior to SVS20 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 BUFY01 to SVS20 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 BUFY01 eye drops in single-dose containers and a medical device called SVS20 eye drops in single-dose containers for people with dry-eye disease. The study is currently recruiting participants at 2 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

DEVICEBUFY01 eye drops in single-dose containers

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

DEVICESVS20 eye drops in single-dose containers

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


Locations(2)

Hôpital des Quinze-Vingts

Paris, France

CHU Saint-Etienne

Saint-Priest-en-Jarez, France

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NCT05865379


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