Comparing BUFY02 and TRB02 eye drops for dry eye disease

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

This test will see if BUFY02 eye drops work as well as TRB02 eye drops to improve signs and symptoms for adults with dry eye disease when used daily for three months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TRB Chemedica International SA (industry)
• Locations: 5 sites (Graz and 4 other locations)
• Trial ID: NCT05865457 on ClinicalTrials.gov

What this trial studies

This interventional non-inferiority comparison will give participants one of two single-dose eye-drop formulations (BUFY02 or TRB02) and follow them over a three-month treatment period. Participants will attend four clinic visits for examinations, complete symptom questionnaires, and return unused medication. The trial measures both objective signs (e.g., Oxford score and other tear-deficiency signs) and patient-reported symptoms, while tracking safety and adverse events. Results will compare effectiveness and tolerability between the two products.

Who should consider this trial

Good fit: Adults with a documented ≥3-month history of bilateral dry eye who use artificial tears and have an eligible Oxford score (4–9) plus at least one objective sign of tear deficiency are the intended participants.

Not a fit: People with severe ocular surface disease, recent ocular surgery or infection, recent use of preservative-containing artificial tears, recent contact-lens changes, pregnancy, breastfeeding, or known hypersensitivity to study components are unlikely to qualify or benefit.

Why it matters

Potential benefit: If BUFY02 is non-inferior to TRB02, patients could have an additional eye-drop option that provides similar symptom relief and safety.

How similar studies have performed: Head-to-head non-inferiority trials of topical eye-drop formulations for dry eye have previously shown that alternative formulations can match established treatments, so the approach is well established.

Eligibility 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.

Where this trial is running

Graz and 4 other locations

• Medical University Graz — Graz, Austria (RECRUITING)
• VIROS — Vienna, Austria (RECRUITING)
• CHRU Brest — Brest, France (RECRUITING)
• Hôpital Bicêtre — Le Kremlin-Bicêtre, France (RECRUITING)
• CHU Nice — Nice, France (RECRUITING)

Conditions: Dry Eye Disease