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New imaging reveals how cyclosporine eye drops calm dry eye inflammation

NCT ID NCT06898853

Knowledge-focused Sponsor: The University of New South Wales 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test whether 0.1% cyclosporine A eye drops can change the number and behavior of immune cells on the eye's surface in people with dry eye disease. Researchers will use a special microscope to watch these cells move over 12 weeks and compare the drops to a lubricating eye drop. The goal is to understand how cyclosporine A reduces inflammation, which could improve future treatments.

What this could mean

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

Active substance
0.1% cyclosporine A eye drops
What this could lead to
If successful, this could help doctors understand exactly how cyclosporine A calms the immune response in dry eye, leading to better-targeted treatments.
What could go wrong
This is a small, early-stage study (60 people) that focuses on measuring immune cells, not on curing symptoms. The results may not apply to all dry eye patients.

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 60 people

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

Started

Jun 2025

Expected to finish

Dec 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

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. 18 years of age and above 2. Participants should meet any two of the following DED diagnostic criteria: i) ocular surface disease index score of ≥23 and ii) Oxford staining score of ≥1 iii) Tear meniscus height \< 0.2 mm. Exclusion Criteria: 1. Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months. 2. Participants with systemic CsA or tacrolimus 3. Known hypersensitivity or contraindication to the study medication or any of its ingredients. 4. Active intraocular inflammation. 5. Contact lens wear or the use of contact lenses in the last 4 weeks. 6. Active eye infections or history of critical illness. 7. DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease. 8. Participants with other ocular co-morbidities and medications for glaucoma. 9. Participants with previous history of ocular surgery in the past 6 months. 10. Any other active or inactive systemic condition, structural abnormality such as eyelid malposition's that in the judgment of the investigator could confound study assessments or limit compliance. 11. Pregnant/breastfeeding women

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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 (DED)

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

    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

  • School of Optometry and Vision Science

    RECRUITING

    Sydney, New South Wales, 2033, Australia

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