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New combo treatment for Sjögren's dry eye shows promise in small trial

NCT ID NCT07171710

Disease control Sponsor: Tianjin Eye Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compares using cyclosporine eye drops alone versus combining them with absorbable punctal plugs for dry eye caused by Sjögren's syndrome. Thirty participants will receive the drops in both eyes and a plug in one eye to see if the combination improves symptoms better. The goal is to find a more effective way to manage this chronic condition.

What this could mean

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

Active substance
0.05% cyclosporine A eye drops and absorbable punctal plugs
What this could lead to
If successful, this combination could offer better relief for dry eye symptoms in Sjögren's syndrome patients than drops alone.
What could go wrong
This is a small, early-stage study with only 30 participants, so results may not apply widely. The punctal plugs are temporary and may cause irritation or infection.

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 30 people

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

Started

Mar 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. The patients aged ≥18 years who had a confirmed diagnosis of Sjögren's syndrome (SS). 2. Dry eye diagnosis required both subjective and objective criteria: participants presented with one or more ocular surface symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with an Ocular Surface Disease Index (OSDI) score of ≥13; Noninvasive Tear Break-Up Time (NIBUT)≤10s and Schirmer I test≤ 5 mm/5 min 3. voluntarily participate in this study and sign written informed consent Exclusion Criteria: 1. Any patient with structural abnormalities (eyelid scars, entropion, trichiasis, etc.); 2. Patients with any inflammation or active structural changes in the iris or anterior chamber; 3. Glaucoma; 4. Patients who have undergone previous ophthalmic surgery or have undergone timely closure; 5. Patients using any topical medications other than artificial tears, 0.1% flumirone eye drops, and 0.05% cyclosporine A eye drops; 6. Patients who received any systemic or topical antibacterial or anti-inflammatory drug treatment 90 days before the start of the study; 7. Patients wearing contact lenses; 8. Patients with corneal infection; 9. Corneal diseases (marginal ulcers, opacity, scars, bullous keratopathy, conjunctival laxity, eyelid ball adhesions or tumors); 10. Pregnancy; 11. Study the changes of immunosuppressive system treatment in the first 90 days.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome Sjogren 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

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Tianjin Eye Hospital

    Tianjin, Tianjin Municipality, China

More trials for these conditions

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