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Nose stimulator could be new hope for Sjogren's dry eyes

NCT ID NCT06626477

Symptom relief Sponsor: Abilion Medical Systems AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tested a device that gently stimulates the inside of the nose to see if it can improve tear production in people with Sjogren's syndrome. 26 participants used either the active device or a sham (fake) device for 6 weeks, then everyone used the active device for another 6 weeks. The main goal was to measure changes in tear production and check for safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intranasal mechanical stimulation device (Walther System)
What this could lead to
If it works, this could offer a drug-free way to ease dry eye symptoms in Sjogren's syndrome.
What could go wrong
This is a small pilot study with only 26 participants. The sham-controlled phase is short (6 weeks), and results may not apply to everyone. The device is not yet proven effective.

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

26 people

The number who actually took part.

Started

Nov 2024

Finished

Jul 2025

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: 1. Age ≥ 18 years at inclusion date 2. Schirmer's test ≤ 5 mm for both eyes 3. NIBUT ≤ 10 s for both eyes 4. Previous positive result of blood test for sample anti-Ro (SS-A) or anti-La (SS-B), as indicated by medical record or lab result shown by the subject. 5. The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments. 6. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study. 7. Anticipated compliance with prescribed treatment and follow-up. Exclusion Criteria: 1. Recently (12 months prior enrolment) undergone nasal, sinus, or ocular surgery. 2. Presence of an ocular or respiratory condition that could affect the study parameters such as active ocular infection/inflammation, glaucoma, diabetic retinopathy, or upper respiratory tract infection per the Investigator's judgement. 3. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation. 4. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation. 5. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason. 6. Previous (within 30 days prior to enrolment) and concurrent treatment with another investigational drug/s or device/s. 7. Subject is pregnant or lactating or planning to get pregnant during the duration of the study.

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

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

Sjogren syndrome

Contacts and locations

Locations

  • Källmarkskliniken AB

    Solna, Stockholm County, 171 54, Sweden

More trials for these conditions

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