Comparing BUFY02 and TRB02 eye drops for dry eye disease
Official title: Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
Run by TRB Chemedica International SA · NCT05865457 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | TRB Chemedica International SA Industry-sponsored |
| Locations | 6 sites (Graz and 5 other locations) |
| Status | Recruiting |
| Started | September 25, 2025 |
| Main results expected | April 2027 |
| Study ends | June 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT05865457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / 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) \> 1.00; * 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.
Where it's running
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Medical University Graz
Graz, Austria Recruiting -
Medical University of Vienna
Vienna, Austria Recruiting -
Viros
Vienna, Austria Recruiting -
CHRU Brest
Brest, France Recruiting -
Hôpital Bicêtre
Le Kremlin-Bicêtre, France Recruiting -
CHU Nice
Nice, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.