RecruitingNot Applicable

Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease

France80 participantsStarted 2026-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Signs

Timeframe: Day 28

Trial details

NCT IDNCT05865379

SponsorTRB Chemedica International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Dry Eye Disease trials