Dry Eye DiseaseBUSTON-01NCT05865379
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
A study testing BUFY01 eye drops in single-dose containers and SVS20 eye drops in single-dose containers in people with Dry Eye Disease, run by TRB Chemedica International SA at 3 sites in 2 countries.
Trial 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… 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?
- BUFY01 eye drops in single-dose containers and SVS20 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
- 3 sitesin 2 countries
- Study dates
- 26 Oct 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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;
Show all 15Show fewer
- 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
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
France2 sites, 2 recruiting
- Recruiting
Hôpital des Quinze-Vingts
Paris
Christiophe Baudouin, +33 1 40 02 13 06, cbaudouin@15-20.fr
- Recruiting
CHU Saint-Etienne
Saint-Priest-en-Jarez
Philippe Gain, +33 4 77 12 77 93, philippe.gain@univ-st-etienne.fr
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven
Heleen Delbeke, +32 16 33 26 74, heleen.delbeke@uzleuven.be
About this study
Official title: Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
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?
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 BUFY01 to SVS20 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
- BUFY01 eye drops in single-dose containers, SVS20 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.
BUFY01 eye drops in single-dose containersDevice
1 to 2 drops in each eye, as often as needed
SVS20 eye drops in single-dose containersDevice
1 to 2 drops in each eye, as often as needed
| Study group | Role | What they receive |
|---|---|---|
| BUFY01 | Experimental | 0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL Receives: Device: BUFY01 eye drops in single-dose containers |
| SVS20 | Active comparator | 0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL Receives: Device: SVS20 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 start26 Oct 2026
- 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
- NCT05865379
- Sponsor's protocol ID
- BUFY01-CT-2101
- Acronym
- BUSTON-01
- Status last verified
- Oct 2026
- First submitted
- 1 May 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
- ClinicalTrials.gov ID
- NCT05865379
- Acronym / sponsor ID
- BUSTON-01 / BUFY01-CT-2101
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- TRB Chemedica International SAIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUFY01 | Experimental | Device: BUFY01 eye drops in single-dose containers0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL |
| SVS20 | Active comparator | Device: SVS20 eye drops in single-dose containers0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BUFY01 eye drops in single-dose containers1 to 2 drops in each eye, as often as needed | Device | BUFY01 |
| SVS20 eye drops in single-dose containers1 to 2 drops in each eye, as often as needed | Device | SVS20 |
Primary outcome
Signs
Time frame: Day 28
Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)
1 secondary outcome
Symptoms
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BUFY01 eye drops in single-dose containers and SVS20 eye drops in single-dose containers in people with Dry Eye Disease, run by TRB Chemedica International SA at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.