NCT05865379 Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
| NCT ID | NCT05865379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TRB Chemedica International SA |
| Condition | Dry Eye Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-06 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-06 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are: * Is BUFY01 non-inferior to SVS20 in terms of signs of DED? * Is BUFY01 non-inferior to SVS20 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 BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.
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) \> 1.00; * 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.
Frequently Asked Questions
Who can join the NCT05865379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05865379 currently recruiting?
Yes, NCT05865379 is actively recruiting participants. Visit ClinicalTrials.gov or contact TRB Chemedica International SA to inquire about joining.
Where is the NCT05865379 trial being conducted?
This trial is being conducted at Paris, France, Saint-Priest-en-Jarez, France.
Who is sponsoring the NCT05865379 clinical trial?
NCT05865379 is sponsored by TRB Chemedica International SA. The trial plans to enroll 80 participants.