BUFY01 versus SVS20 eye drops for dry eye disease

Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation

We will test whether BUFY01 eye drops work as well as SVS20 eye drops to improve signs and symptoms in adults with dry eye disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TRB Chemedica International SA (Industry-sponsored)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT05865379 on ClinicalTrials.gov

What this trial studies

Participants are assigned to receive either BUFY01 or SVS20 single‑dose eye drops and will use the allocated treatment every day for three months. They will attend four clinic visits for ocular examinations, complete symptom questionnaires, and return unused study medication. The trial is designed as a head‑to‑head non‑inferiority comparison of effects on objective signs (e.g., ocular surface staining) and patient‑reported symptoms, with monitoring for safety and tolerability. Procedures take place at participating ophthalmology centers in France.

Who should consider this trial

Good fit: Adults with a documented ≥3‑month history of bilateral dry eye who need artificial tears, have at least one eye with Oxford score 4–9 and at least one objective sign of tear deficiency, who have health insurance and can attend the scheduled visits are ideal candidates.

Not a fit: People with severe or non‑DED ocular surface disease (for example severe blepharitis, seasonal allergy, recent ocular surgery/injury, unstable glaucoma), recent preservative‑containing artificial tear use, recent contact lens initiation, pregnancy or breastfeeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could provide an alternative eye‑drop option with similar effectiveness and safety for people with dry eye disease.

How similar studies have performed: Other non‑inferiority trials and comparable preservative‑free lubricating eye‑drop formulations have demonstrated similar improvements in signs and symptoms, while BUFY01 itself appears to be a newer formulation being directly compared to SVS20.

Eligibility criteria

Inclusion Criteria includes:

* 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 includes:

* 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

Paris and 1 other locations

• Hôpital des Quinze-Vingts — Paris, France (Recruiting)
• CHU Saint-Etienne — Saint-Priest-en-Jarez, France (Recruiting)

Conditions Dry Eye Disease