Actively Recruiting
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Led by TRB Chemedica International SA · Updated on 2026-02-05
80
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears
- At least one eye with Oxford score �3E�3D 4 and �3C= 9
- At least one objective sign of tear deficiency in at least one eligible eye
- Having health insurance
You will not qualify if you...
- Wearing contact lenses started within the last 2 months
- Best-corrected visual acuity less than 1/10
- Severe dry eye disease with severe blepharitis
- Seasonal allergy
- Any ocular surface issues not related to dry eye disease
- History of ocular trauma, infection, or inflammation unrelated to dry eye disease
- History of ocular surgery, including laser surgery
- Unstable glaucoma
- Use of artificial tears with preservative within the last 2 weeks
- Use of systemic or local medications listed in the study
- Known hypersensitivity to any component of the study treatments
- Pregnancy or breastfeeding
- Participation in another clinical study within the last 90 days
- Legally restricted autonomy, freedom of decision and action
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hôpital des Quinze-Vingts
Paris, France
Actively Recruiting
2
CHU Saint-Etienne
Saint-Priest-en-Jarez, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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