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 A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time.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.
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.
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.
Parallel
0.1% Ciclosporin A eye drops
DrugThe active intervention arm has CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) and mineral oils lubricating eye drops - Cationorm (CSL Seqirus, Parkville, Victoria)
Mineral oils eye drops
DrugThis arm is the comparator arm has mineral oils lubricating eye drops - Cationorm (CSL Seqirus, Parkville, Victoria)
Corneal epithelial immune cell density
Evaluation of change in corneal epithelial immune cell density using in vivo confocal microscopy. The outcome will be measured as the number of immune cells per square millimeter (cells/mm²) of corneal epithelium. Higher values indicate increased immune cell infiltration and greater corneal inflammation.
Conjunctival immune cell density
Evaluation of change in conjunctival immune cell density using impression cytology and flow cytometry. The outcome will be measured as the percentage change in specific immune cell populations (including CD45, CD3, CD4, CD8, CD11c, and HLA-DR positive cells). Higher percentage indicates an increase in immune cell density.
Tear cytokine concentrations
Evaluation of change in tear film inflammation through measurement of cytokine concentrations in tear fluid. The concentration of each inflammatory cytokine (IL-2, IL-4, IL-6, IL-12, IL-17, IL-23, IFN-γ) will be individually measured and reported in picograms per milliliter (pg/mL). Higher concentrations indicate more severe ocular surface inflammation.
Tear film break-up time
Evaluation of change in tear-film break-up time observed through slit-lamp biomicroscopy after fluorescein dye instillation in the eye. The measurement is recorded in seconds, with lower values indicating decreased tear film stability and more severe dry eye disease. A value of \<10 seconds is considered abnormal
Ocular surface disease index score
Evaluation of change in dry eye symptoms using the Ocular Surface Disease Index (OSDI) questionnaire. The OSDI is a validated 12-item questionnaire that assesses symptoms related to dry eye disease and their impact on vision-related functioning. The scale ranges from 0 to 100 points, with higher scores indicating more severe dry eye symptoms
Ocular surface staining score
Evaluation of change in ocular surface staining score using the Oxford Staining grading. The Oxford Staining Score is a standardized grading system that quantifies corneal and conjunctival epithelial damage by assessing the degree of fluorescein and/or lissamine green staining. The scale ranges from 0 to 5 points (or grades), with higher scores indicating more severe ocular surface damage.
Click on the lead sponsor to view all of their trials.
The University of New South Wales
Lead sponsor
University of Melbourne
Collaborator
