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

TRB Chemedica

Status

Not yet enrolling

Conditions

Dry Eye Disease

Treatments

Device: BUFY02 eye drops in single-dose containers

Device: TRB02 eye drops in single-dose containers

Study type

Interventional

Funder types

Industry

Identifiers

NCT05865457

BUFY02-CT-2201

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.