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

NCT06898853 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-05

No results posted yet for this study

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 A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time.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

Conditions

  • Dry Eye Disease (DED)

Interventions

DRUG

0.1% Ciclosporin A eye drops

The active intervention arm has CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) and mineral oils lubricating eye drops - Cationorm (CSL Seqirus, Parkville, Victoria)

DRUG

Mineral oils eye drops

This arm is the comparator arm has mineral oils lubricating eye drops - Cationorm (CSL Seqirus, Parkville, Victoria)

Sponsors & Collaborators

Principal Investigators

  • Fiona Stapleton Professor, PhD · The University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06898853 on ClinicalTrials.gov