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Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
Led by TRB Chemedica International SA · Updated on 2026-06-03
80
Participants Needed
2
Research Sites
8 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of BUFY01 compared to SVS20 in treating patients with dry eye disease. The study aims to determine if BUFY01 is not worse than SVS20 in improving both the signs and symptoms of dry eye disease. This is a randomized, quadruple-masked interventional trial sponsored by TRB Chemedica International SA. Participants will be randomly assigned to receive either BUFY01 or SVS20 eye drops, both containing 0.18% sodium hyaluronate in single-dose containers. Participants are instructed to apply 1 to 2 drops in each eye as often as needed daily for 3 months. The study includes four visits to the trial site during this period. During the study, participants will be examined by investigators and asked to complete several questionnaires about their symptoms. Researchers will monitor the signs of dry eye disease at 28 days as the primary outcome and symptoms at the same time as secondary outcomes. Participants are also asked to return any unused study treatment. The total study duration involves daily treatment and follow-up through the 3-month period.
CONDITIONS
Brief 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 64 4 and 64 9
- At least one objective sign of tear deficiency in at least one eligible eye
- Having health insurance
- Participants aged 18 years or older
You will not qualify if you...
- Wearing contact lenses starting within the last 2 months
- Best-corrected visual acuity (BCVA) greater than 1.00
- 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 not related 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 affecting the eye as listed
- Known hypersensitivity to any ingredient in 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive either BUFY01 or SVS20 eye drops as needed to treat dry eye disease.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 2 locations
1
Hôpital des Quinze-Vingts
Paris, France
Actively Recruiting
2
CHU Saint-Etienne
Saint-Priest-en-Jarez, France
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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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