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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06898853




Registration number
NCT06898853
Ethics application status
Date submitted
9/03/2025
Date registered
27/03/2025

Titles & IDs
Public title
The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes
Scientific title
The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Ocular Surface Innate and Adaptive Immune Response in Dry Eye Disease
Secondary ID [1] 0 0
UNSW IIT Protocol 202412001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Disease (DED) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 0.1% Ciclosporin A eye drops
Treatment: Drugs - Mineral oils eye drops

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

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


Treatment: Drugs: 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)

Treatment: Drugs: Mineral oils eye drops
This arm is the comparator arm has mineral oils lubricating eye drops - Cationorm (CSL Seqirus, Parkville, Victoria)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Corneal epithelial immune cell density
Timepoint [1] 0 0
Baseline, 4-weeks, and 12-weeks
Primary outcome [2] 0 0
Conjunctival immune cell density
Timepoint [2] 0 0
Baseline, 4-weeks and 12-weeks.
Secondary outcome [1] 0 0
Tear cytokine concentrations
Timepoint [1] 0 0
Baseline and 12-weeks.
Secondary outcome [2] 0 0
Tear film break-up time
Timepoint [2] 0 0
Baseline, 4-weeks, and 12-weeks.
Secondary outcome [3] 0 0
Ocular surface disease index score
Timepoint [3] 0 0
Baseline, 4-weeks and 12-weeks.
Secondary outcome [4] 0 0
Ocular surface staining score
Timepoint [4] 0 0
Baseline, 4-weeks and 12-weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
School of Optometry and Vision Science - Sudney
Recruitment postcode(s) [1] 0 0
2033 - Sudney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fiona Stapleton Professor, PhD
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fiona Stapleton Professor, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 0418868234
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06898853