12-week 0.1% ciclosporin A eye drops to reduce immune cells on the eye surface in dry eye

The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Ocular Surface Innate and Adaptive Immune Response in Dry Eye Disease

This trial will try 0.1% ciclosporin A eye drops for people with dry eye to see if the drops reduce inflammatory immune cells on the eye surface compared with mineral oil drops.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of New South Wales (Academic / other)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT06898853 on ClinicalTrials.gov

What this trial studies

Adults with dry eye who meet symptom and sign criteria will receive either 0.1% ciclosporin A eye drops or mineral oil drops for 12 weeks. Researchers will use in vivo confocal microscopy and conjunctival sampling to measure changes in immune cell populations and activation markers on the ocular surface. Participants must meet specific diagnostic thresholds for dry eye and must not have recent use of topical or systemic immunomodulatory therapies or certain ocular comorbidities. Outcomes focus on cellular and molecular changes rather than symptomatic endpoints alone, providing mechanistic information about how ciclosporin A affects ocular surface immunity.

Who should consider this trial

Good fit: Adults aged 18 and over with dry eye who meet at least two diagnostic criteria (OSDI ≥23, Oxford staining ≥1, or tear meniscus height <0.2 mm) and who are not using topical or systemic immunomodulators are ideal candidates.

Not a fit: Patients with cicatricial conjunctival disease (for example Stevens–Johnson syndrome), recent ocular surgery, active ocular infection, recent contact lens use, or recent use of topical/systemic anti-inflammatory eye treatments are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, the trial could show that topical ciclosporin A reduces ocular surface inflammation and help tailor anti-inflammatory treatment for people with dry eye.

How similar studies have performed: Topical ciclosporin has previously shown improvements in signs and symptoms of dry eye in other trials, while using high-resolution imaging and cell phenotyping to track specific ocular surface immune-cell changes is a more novel approach.

Eligibility criteria

Inclusion Criteria:

1. 18 years of age and above
2. 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.

Exclusion Criteria:

1. Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.
2. Participants with systemic CsA or tacrolimus
3. Known hypersensitivity or contraindication to the study medication or any of its ingredients.
4. Active intraocular inflammation.
5. Contact lens wear or the use of contact lenses in the last 4 weeks.
6. Active eye infections or history of critical illness.
7. DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease.
8. Participants with other ocular co-morbidities and medications for glaucoma.
9. Participants with previous history of ocular surgery in the past 6 months.
10. 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.
11. Pregnant/breastfeeding women

Where this trial is running

Sydney, New South Wales

• School of Optometry and Vision Science — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Fiona Stapleton Professor, PhD — The University of New South Wales
• Study coordinator: Fiona Stapleton Professor, PhD

Conditions Dry Eye Disease