NCT05865379RecruitingNot Applicable
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
TRB Chemedica International SA3 sites in 2 countries80 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Signs
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Wear of contact lenses starting within the last 2 months;
- •Best-corrected visual acuity (BCVA) > 1.00;
- •Severe DED with one of the listed conditions:
- •Severe blepharitis;
- •Seasonal allergy;
- •Any issues of the ocular surface not related to DED;
- •History of ocular trauma, infection or inflammation not related to DED;
- •History of ocular surgery, including laser surgery;
- •Unstable glaucoma;
- •Use of artificial tears with preservative within the last 2 weeks;
- •Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:
- •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.
Arms & Interventions
BUFY01
Experimental
0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL
Intervention: BUFY01 eye drops in single-dose containers (Device)
SVS20
Active Comparator
0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL
Intervention: SVS20 eye drops in single-dose containers (Device)
Outcomes
Primary Outcomes
Signs
Time Frame: Day 28
Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)
Secondary Outcomes
- Symptoms(Day 28)
Investigators
Study Sites (3)
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