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

ConditionDry Eye Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorTRB Chemedica International SA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Wear of contact lenses starting within the last 2 months;

Best-corrected visual acuity (BCVA) > 1.00;

Severe blepharitis;

Seasonal allergy;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: BUFY02Experimental treatment 1 intervention

Group B: TRB02Active comparator 1 intervention

Trial outcomes

Primary outcomes

Signs

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

Time frame

Day 28

Secondary outcomes

Symptoms

Change from baseline in Ocular Surface Disease Index

Time frame

Day 28

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TRB Chemedica International SA

Lead sponsor

Source ClinicalTrials.gov

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