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NCT Number: NCT05865457

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BUFY02 eye drops in single-dose containers

Device

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

TRB02 eye drops in single-dose containers

Device

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

Primary outcomes

  1. Signs

    Time frame: Day 28

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

Secondary outcomes

  1. Symptoms

    Time frame: Day 28

    Change from baseline in Ocular Surface Disease Index

Sponsors and collaborators

Lead sponsor

TRB Chemedica International SA

Industry

Registry information

Official study title

Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation

Acronym: BUSTON-02

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 18, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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