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RecruitingNCT05865457BUSTON-02Updated Sep 29, 2026

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

An interventional study of BUFY02 eye drops in single-dose containers and TRB02 eye drops in single-dose containers in Dry Eye Disease, sponsored by TRB Chemedica International SA. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by TRB Chemedica International SA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dry Eye Disease

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    BUFY02

    0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL

    Device: BUFY02 eye drops in single-dose containers

  • Active comparator
    TRB02

    0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL

    Device: TRB02 eye drops in single-dose containers

Interventions

  • DeviceBUFY02 eye drops in single-dose containers

    1 to 2 drops in each eye, as often as needed

  • DeviceTRB02 eye drops in single-dose containers

    1 to 2 drops in each eye, as often as needed

05

What researchers measure

Primary outcomes

  1. Signs

    Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)

    Time frame: Day 28

Secondary outcomes

  1. Symptoms

    Change from baseline in Ocular Surface Disease Index

    Time frame: Day 28

06

Study locations

6 of 6 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05865457
Lead sponsor
TRB Chemedica International SA
Responsible party
Sponsor
First posted
May 18, 2023
Start date
Sep 25, 2025
Primary completion
Apr 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 29, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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