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

Dry Eye Disease Clinical Trial

— BUSTON-02  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05865457
• Other study ID #: BUFY02-CT-2201
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: TRB Chemedica International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) < 1/10;

• 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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• BUFY02 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed
• TRB02 eye drops in single-dose containers
1 to 2 drops in each eye, as often as needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica International SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signs	Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)	Day 28
Secondary	Symptoms	Change from baseline in Ocular Surface Disease Index	Day 28