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NCT05865457From ClinicalTrials.govRecruiting

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease

Efficacy and Safety of BUFY02 Versus TRB02 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
25 September 2025
Main results due
April 2027
Study sites
6
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 include:

* 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 include:

* 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 BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are:

* Is BUFY02 non-inferior to TRB02 in terms of signs of DED? * Is BUFY02 non-inferior to TRB02 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 BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.

Study sites(6)

  • Medical University Graz

    Graz, Austria

    Recruiting

  • Medical University of Vienna

    Vienna, Austria

    Recruiting

  • VIROS

    Vienna, Austria

    Recruiting

  • CHRU Brest

    Brest, France

    Recruiting

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, France

    Recruiting

  • CHU Nice

    Nice, France

    Recruiting

Showing 6 of 6 sites. 6 of the 6 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 NCT05865457. 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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Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease | Trialion