Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
- Dry Eye Disease
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- TRB Chemedica International SA
- Enrolment target
- 80
- Started
- September 2026
- Main results due
- April 2027
- Study sites
- 3
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria includes: * 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 includes: * 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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(3)
UZ Leuven
Leuven, Belgium
Recruiting
Hôpital des Quinze-Vingts
Paris, France
Recruiting
CHU Saint-Etienne
Saint-Priest-en-Jarez, France
Recruiting
Showing 3 of 3 sites. 3 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05865379. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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