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Efficacy and Safety of BUFY02 Versus TRB02 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
5
Research Sites
8 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two treatments, BUFY02 and TRB02, for people with dry eye disease to see if BUFY02 works as well as TRB02 in improving signs and symptoms of the condition. This is a randomized, quadruple-masked interventional study sponsored by TRB Chemedica International SA, focused on evaluating effects on dry eye disease over a three-month period. Participants will be assigned to use either BUFY02 or TRB02 eye drops, both containing 0.3% Sodium Hyaluronate but with different buffers, administered as 1 to 2 drops in each eye as needed daily. The study lasts for three months, with participants visiting the trial site at four scheduled timepoints. They will use the assigned treatment every day throughout the study and return any unused medication. During the study, participants will have eye examinations and complete several questionnaires to assess the signs and symptoms of dry eye disease. Researchers will measure the main outcome of signs on day 28 and symptoms on day 28. Safety and treatment adherence will also be monitored. The study aims to provide a thorough comparison between BUFY02 and TRB02 treatments over the participation period.
CONDITIONS
Brief Title
Efficacy and Safety of BUFY02 Versus TRB02 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 4 and 9
- At least one objective sign of tear deficiency in at least one eligible eye
- Having health insurance
- Age 18 years or older
You will not qualify if you...
- Wear of 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 listed in the study
- Known hypersensitivity to any constituent 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
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 use BUFY02 or TRB02 eye drops as often as needed for dry eye disease.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 5 locations
1
Medical University Graz
Graz, Austria
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2
VIROS
Vienna, Austria
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3
CHRU Brest
Brest, France
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4
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
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5
CHU Nice
Nice, 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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