Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06898853

The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes

Led by The University of New South Wales · Updated on 2026-05-05

60

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

Sponsors

T

The University of New South Wales

Lead Sponsor

U

University of Melbourne

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time.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.

CONDITIONS

Official Title

The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed dry eye disease meeting at least two of the following: ocular surface disease index score of 23 or higher, Oxford staining score of 1 or higher, or tear meniscus height less than 0.2 mm
Not Eligible

You will not qualify if you...

  • Use of steroids, ciclosporin, lifitegrast, or any anti-inflammatory eye drops within the past 6 months
  • Use of systemic ciclosporin A or tacrolimus
  • Known allergy or contraindication to study medication or its ingredients
  • Active inflammation inside the eye
  • Contact lens use currently or within the past 4 weeks
  • Active eye infections or history of critical illness
  • Dry eye disease caused by Steven-Johnson syndrome or cicatricial conjunctival disease
  • Other eye diseases or use of glaucoma medications
  • Eye surgery within the past 6 months
  • Any other active or inactive systemic condition or eyelid abnormality that may affect study assessments or compliance
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

School of Optometry and Vision Science

Sydney, New South Wales, Australia, 2033

Actively Recruiting

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Research Team

F

Fiona Stapleton Professor, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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