Treatment of Ocular Surface Inflammations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical Cyclosporine 1%.
- Who it may be relevant to
- Registry conditions: Ocular Surface Allergy, Conjunctivitis, Allergic, Blepharoconjunctivitis. Basic parameters: 4 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Ocular Surface Inflammations With 1% Cyclosporine (Ikervis) Eye Drops
Overview
The goal of this clinical trial is to learn if topical Cyclosporine 1% works to treat severe allergic ocular surface inflammation in pediatric population. The study will evaluate the efficacy and safety of topical Cyclosporine 1%. The main questions it aims to answer are: Does topical Cyclosporine 1% lower the number of times participants need to use a rescue steroid? What medical problems do participants have when taking topical Cyclosporine 1%? Participants will: Take topical Cyclosporine 1% every day for months. Visit the clinic once every 2-6 weeks for checkups and tests. Keep a diary of their symptoms and the number of times they use a rescue medication. spelling errors/typos and update as appropriate.
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of topical Cyclosporine 1% for the treatment of severe allergic ocular surface inflammation in the pediatric population.
The main questions this study aims to answer are:
Does topical Cyclosporine 1% reduce the frequency of rescue steroid use? What adverse events occur during treatment with topical Cyclosporine 1%?
Patients with severe ocular surface inflammation who are prescribed topical Cyclosporine 1% as part of routine clinical care will be prospectively observed. Participants will receive topical Cyclosporine 1% daily for several months and attend follow-up visits every 2 to 6 weeks. During these visits, slit-lamp examination, non-invasive tear film evaluation, eyelid morphology assessment, and anterior segment evaluation will be performed. Participants will also maintain a diary documenting symptoms and the frequency of rescue medication use throughout the study period.
Interventions
- Drug Topical Cyclosporine 1%
Dosage may differ from severe dry eye indication
Primary outcome measures
- subjective ocular symptoms [Time frame: Baseline to 36 months]
- Frequency of Rescue Steroid Use [Time frame: Baseline to 36 months]
- Oxford Grading Scale Score for Ocular Surface Staining [Time frame: Baseline to 36 months]
Secondary outcome measures (5)
- Non-Invasive Tear Break-Up Time (NIBUT) [Time frame: Baseline to 36 months]
- Lipid Layer Thickness (LLT) Grade [Time frame: Baseline to 36 months]
- Tear Meniscus Height (TMH) [Time frame: Baseline to 36 months]
- Meibomian Gland Dropout Percentage [Time frame: Baseline to 36 months]
- Meibomian Gland Morphological Abnormality Score [Time frame: Baseline to 36 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Hungary · 1 center
- Semmelweis University Department of Ophthalmology — Budapest
Identifiers
NCT: NCT07732855 · NNGYK/23414-1/2025