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

NCT06898853 | Recruiting DMC

• 1 other identifier: UNSW IIT Protocol 202412001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time.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

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 4-weeks, and 12-weeks

• 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.

  Baseline, 4-weeks and 12-weeks.

Secondary Outcomes (4)

• Tear cytokine concentrations

  Baseline and 12-weeks.

• Tear film break-up time

  Baseline, 4-weeks, and 12-weeks.

• Ocular surface disease index score

  Baseline, 4-weeks and 12-weeks.

• Ocular surface staining score

  Baseline, 4-weeks and 12-weeks.

Study Arms (2)

Group A - CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) once daily at night-time + Cationorm

EXPERIMENTAL

Drug: 0.1% Ciclosporin A eye drops; Drug: Mineral oils eye drops

Group B - Cationorm (CSL Seqirus, Parkville, Victoria) four times daily in both eyes for 12-weeks.

ACTIVE COMPARATOR

Drug: Mineral oils eye drops

Interventions

0.1% Ciclosporin A eye drops DRUG

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

Group A - CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) once daily at night-time + Cationorm

Mineral oils eye drops DRUG

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

Group A - CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) once daily at night-time + Cationorm; Group B - Cationorm (CSL Seqirus, Parkville, Victoria) four times daily in both eyes for 12-weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Contact lens wear or the use of contact lenses in the last 4 weeks.
• Active eye infections or history of critical illness.
• DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease.
• Participants with other ocular co-morbidities and medications for glaucoma.
• Participants with previous history of ocular surgery in the past 6 months.
• 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.
• Pregnant/breastfeeding women

Sponsors & Collaborators

• The University of New South Wales: lead
• University of Melbourne: collaborator

Study Sites (1)

School of Optometry and Vision Science

Sydney, New South Wales, 2033, Australia

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Fiona Stapleton Professor, PhD

  The University of New South Wales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Stapleton Professor, PhD

CONTACT

+61 0418868234; f.stapleton@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: A single-center, examiner-blind, randomized, controlled clinical trial to evaluate and compare the effect of CsA 0.1% with its vehicle on the ocular surface EIC density, morphology, inflammatory markers and signs, symptoms in DED. Intervention: Subjects will be allocated randomly in a 1:1 ratio in one of the following groups. Group A - CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) once daily at night-time + Cationorm (CSL Seqirus, Parkville, Victoria) four times daily in both eyes for 12-weeks. Group B - Cationorm (CSL Seqirus, Parkville, Victoria) four times daily in both eyes for 12-weeks. Follow-up period: 12-weeks Total study period: 14-weeks

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 27, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

AU (1)