Status:
NOT_YET_RECRUITING
The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes
Lead Sponsor:
The University of New South Wales
Collaborating Sponsors:
University of Melbourne
Conditions:
Dry Eye Disease (DED)
Eligibility:
All Genders
18+ years
Phase:
NA
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 dis...
Detailed Description
The immune system plays a pivotal role in dry eye disease (DED) pathogenesis. An increased level of several tear cytokines, chemokines, expression of HLA-DR molecules and activation of antigen present...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06898853
Start Date
May 1 2025
End Date
September 30 2026
Last Update
April 2 2025
Active Locations (1)
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1
School of Optometry and Vision Science
Sudney, New South Wales, Australia, 2033