Topical Cyclosporine 1% for Severe Pediatric Ocular Surface Inflammation
Official title: Treatment of Ocular Surface Inflammations With 1% Cyclosporine (Ikervis) Eye Drops
Run by Semmelweis University · NCT07732855 · Data updated 2026-11-12
This study tests whether daily topical Cyclosporine 1% helps children with severe allergic eye inflammation and if it reduces the need for rescue steroids.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years to 60 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest, Pest County) |
| Status | Recruiting |
| Started | June 10, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07732855 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children with severe ocular surface inflammation who are already prescribed topical Cyclosporine 1% as part of routine care and can commit to follow-up visits.
✕Probably not a fit
Patients unlikely to benefit include those with recent eye surgery or other conditions that preclude accurate ocular surface measurements.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows pediatric patients with severe ocular surface inflammation who are treated with topical Cyclosporine 1% as part of routine care. Participants will use the eye drops daily for several months and have eye exams and tear film assessments at 2–6 week visits. They will document symptoms and any use of rescue steroids in a diary to help gauge safety and potential benefits. Slit-lamp exams, tear film measurements, eyelid and anterior segment evaluations will be performed during follow-up. The study aims to determine safety and whether Cyclosporine 1% lowers rescue steroid requirements.
Why it matters
Potential benefit: If successful, the approach could reduce the need for rescue steroids and improve management of pediatric ocular surface inflammation.
How similar studies have gone: Previous studies in similar inflammatory eye conditions have shown some benefit with topical cyclosporine, but results vary and this setting is observational.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ocular surface inflammatory disease cornea inflammation -keratitis Exclusion Criteria: * eye surgery within 1 year, lack of fitness for the objective ocular surface measurments
Where it's running
-
Semmelweis University Department of Ophthalmology
Budapest, Pest County, Hungary Recruiting
Study contacts
- Principal investigator: Amarilla Barcsay-Veres, MD — Semmelweis University
- Study coordinator: Lim Lu Hyoun
- Email: luhyoun21c@gmail.com
- Phone: +3614591500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.