NCT06898853 The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes
| NCT ID | NCT06898853 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of New South Wales |
| Condition | Dry Eye Disease (DED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dry eye disease (DED) is a common, long-lasting condition that affects the surface of the eye. It happens when there's a problem with tear production or quality, which can lead to inflammation and discomfort. The immune system plays a big role in how DED develops and continues. Researchers have found that in people with DED, there are more immune cells and inflammatory substances in the tears and on the eye's surface. This includes various types of immune cells, like T cells and dendritic cells, which are part of the body's defense system. The first treatment for DED is usually artificial tears, but because the condition is chronic and can flare up, clinicians often use anti-inflammatory treatments too. One such treatment is cyclosporine A (CsA), which comes as eye drops. CsA works by reducing inflammation and affects how immune cells behave. Researchers can study the immune cells on the eye's surface using a special microscopy technique called in vivo confocal microscopy (IVCM). A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time. In the current study, researchers want to compare 0.1% CsA with a lubricating eye drop to see how they affect the immune cells on the eye's surface. The researchers will use Fun-IVCM to look at the number, shape, and movement of immune cells of the eye. The researchers will also collect samples from the eye's surface and tears to measure various markers of inflammation. The goal is to better understand how CsA works in treating DED by directly observing its effects on the immune response in the eye, which is unexplored. This could help improve treatments for people suffering from this condition and expand the use of CsA in DED.
Eligibility Criteria
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
Contact & Investigator
Fiona Stapleton Professor, PhD
PRINCIPAL INVESTIGATOR
The University of New South Wales
Frequently Asked Questions
Who can join the NCT06898853 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease (DED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06898853 currently recruiting?
Yes, NCT06898853 is actively recruiting participants. Contact the research team at f.stapleton@unsw.edu.au for enrollment information.
Where is the NCT06898853 trial being conducted?
This trial is being conducted at Sydney, Australia.
Who is sponsoring the NCT06898853 clinical trial?
NCT06898853 is sponsored by The University of New South Wales. The principal investigator is Fiona Stapleton Professor, PhD at The University of New South Wales. The trial plans to enroll 60 participants.