Dry Eye DiseaseBUSTON-02NCT05865457
Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease
A study testing BUFY02 eye drops in single-dose containers and TRB02 eye drops in single-dose containers in people with Dry Eye Disease, run by TRB Chemedica International SA at 6 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- BUFY02 eye drops in single-dose containers and TRB02 eye drops in single-dose containers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 25 Sep 2025to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Austria3 sites, 3 recruiting
- Recruiting
Medical University Graz
Graz
Jutta Horwath-Winter, Dr, +43 316 385 80807, jutta.horwath@medunigraz.at
- Recruiting
Medical University of Vienna
Vienna
Doreen Schmidl-Schordje, +43 1 40 400 29810, doreen.schmidl@meduniwien.ac.at
- Recruiting
VIROS
Vienna
Stefan Palkovits, Dr, +43 1 91 021 57573, stefan.palkovits@oegk.at
France3 sites, 3 recruiting
- Recruiting
CHRU Brest
Brest
Beatrice Cochener, Prof., +33 2 98 22 34 40, beatrice.cochener@univ-brest.fr
- Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre
Marc Labetoulle, +33 1 45 21 36 90, marc.labetoulle@aphp.fr
- Recruiting
CHU Nice
Nice
Stéphanie Baillif, Prof., +33 4 92 03 8025, baillif.s@chu-nice.fr
About this study
Official title: Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
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?
Read more
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.
- Conditions
- Dry Eye Disease
- Being tested
- BUFY02 eye drops in single-dose containers, TRB02 eye drops in single-dose containers
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUFY02 eye drops in single-dose containersDevice
1 to 2 drops in each eye, as often as needed
TRB02 eye drops in single-dose containersDevice
1 to 2 drops in each eye, as often as needed
| Study group | Role | What they receive |
|---|---|---|
| BUFY02 | Experimental | 0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL Receives: Device: BUFY02 eye drops in single-dose containers |
| TRB02 | Active comparator | 0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL Receives: Device: TRB02 eye drops in single-dose containers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs
Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)
Measured: Day 28
Secondary outcomes (1)
Symptoms
Change from baseline in Ocular Surface Disease Index
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start25 Sep 2025
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865457
- Sponsor's protocol ID
- BUFY02-CT-2201
- Acronym
- BUSTON-02
- Status last verified
- Sep 2026
- First submitted
- 9 May 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No