Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
ConditionDry Eye Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTRB Chemedica International SA
About this trial
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 criteria
Qualifiers
At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;
At least one eye with Oxford score ≥ 4 and ≤ 9;
At least one objective sign of tear deficiency (in at least one eligible eye);
Having a health insurance.
Disqualifiers
Wear of contact lenses starting within the last 2 months;
Best-corrected visual acuity (BCVA) > 1.00;
Severe blepharitis;
Seasonal allergy;
Trial design
Treatments tested in this trial
- BUFY01 eye drops in single-dose containers
- SVS20 eye drops in single-dose containers
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov