Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease
- Conditions
- Dry Eye Disease
- Interventions
- Device: TRB02 eye drops in single-dose containersDevice: BUFY02 eye drops in single-dose containers
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRB02 TRB02 eye drops in single-dose containers 0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL BUFY02 BUFY02 eye drops in single-dose containers 0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL
- 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