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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of New South Wales

About this trial

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 A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time.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

Qualifiers

18 years of age and above

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.

Disqualifiers

Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.

Participants with systemic CsA or tacrolimus

Known hypersensitivity or contraindication to the study medication or any of its ingredients.

Active intraocular inflammation.

Trial design

Treatments tested in this trial

  • 0.1% Ciclosporin A eye drops
  • Mineral oils eye drops

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The University of New South Wales

Lead sponsor

University of Melbourne

Collaborator