Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease (BUSTON-02)

June 1, 2026 updated by: TRB Chemedica International SA

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?

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University Graz
        • Contact:
      • Vienna, Austria
  • France
      • Brest, France
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Hôpital Bicêtre
        • Contact:
      • Nice, France
        • Recruiting
        • CHU Nice
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BUFY02
0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL
Device: BUFY02 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
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
1 to 2 drops in each eye, as often as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signs
Time Frame: Day 28
Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: Day 28
Change from baseline in Ocular Surface Disease Index
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRB Chemedica International SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUFY02-CT-2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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