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New eye drop BUFY01 takes on SVS20 in dry eye showdown

NCT ID NCT05865379

Symptom relief Sponsor: TRB Chemedica International SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests whether a new eye drop, BUFY01, works as well as an existing one, SVS20, for people with dry eye disease. About 80 participants will use one of the two drops daily for three months. Researchers will check eye health and ask about symptoms to see if the treatments are similarly effective and safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Saint-Etienne

    RECRUITING

    Saint-Priest-en-Jarez, France

  • Hôpital des Quinze-Vingts

    RECRUITING

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.