Treatment of Ocular Surface Inflammations With 1% Cyclosporine (Ikervis) Eye Drops
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Semmelweis University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- subjective ocular symptoms
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 4 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Chronic ocular allergic inflammation
Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation
Intervention: Topical Cyclosporine 1% (Drug)
Blepharokeratoconjunctivitis
Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well
Intervention: Topical Cyclosporine 1% (Drug)
Outcomes
Primary Outcomes
subjective ocular symptoms
Time Frame: Baseline to 36 months
Subjective ocular symptoms, including tearing, photosensitivity, itching and discharge, were quantified on a visual analogue scale (VAS) ranging from 0 to 10. The maximum score was 40, with the most severe symptom score being. Reference: Bonini, S., Sacchetti, M., Mantelli, F. \& Lambiase, A. Clinical grading of vernal keratoconjunctivitis. Curr. Opin. Allergy Clin. Immunol. 7, 436-441 (2007).
Frequency of Rescue Steroid Use
Time Frame: Baseline to 36 months
Number of rescue topical corticosteroid treatments required during the study period.
Oxford Grading Scale Score for Ocular Surface Staining
Time Frame: Baseline to 36 months
Severity of allergic ocular surface inflammation will be assessed by slit-lamp examination using the Oxford Grading Scale for ocular surface staining. Scores range from 0 to 5, with higher scores indicating more severe ocular surface staining and worse inflammation.
Secondary Outcomes
- Non-Invasive Tear Break-Up Time (NIBUT)(Baseline to 36 months)
- Lipid Layer Thickness (LLT) Grade(Baseline to 36 months)
- Tear Meniscus Height (TMH)(Baseline to 36 months)
- Meibomian Gland Dropout Percentage(Baseline to 36 months)
- Meibomian Gland Morphological Abnormality Score(Baseline to 36 months)
Investigators
Luhyoun Lim
Medical Doctor
Semmelweis University