Treatment of Ocular Surface Inflammations
Treatment of Ocular Surface Inflammations With 1% Cyclosporine (Ikervis) Eye Drops
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lim Lu Hyoun
- Número de teléfono: +3614591500
- Correo electrónico: luhyoun21c@gmail.com
Ubicaciones de estudio
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Pest County
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Budapest, Pest County, Hungría, 1085
- Reclutamiento
- Semmelweis University Department of Ophthalmology
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Contacto:
- Amarilla Barcsay-Veres, MD.PhD.
- Número de teléfono: 003614591500
- Correo electrónico: veres.amarilla@semmelweis.hu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Chronic ocular allergic inflammation
Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation
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Dosage may differ from severe dry eye indication
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Blepharokeratoconjunctivitis
Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well
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Dosage may differ from severe dry eye indication
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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subjective ocular symptoms
Periodo de tiempo: Baseline to 36 months
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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).
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Baseline to 36 months
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Frequency of Rescue Steroid Use
Periodo de tiempo: Baseline to 36 months
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Number of rescue topical corticosteroid treatments required during the study period.
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Baseline to 36 months
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Oxford Grading Scale Score for Ocular Surface Staining
Periodo de tiempo: Baseline to 36 months
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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.
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Baseline to 36 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Non-Invasive Tear Break-Up Time (NIBUT)
Periodo de tiempo: Baseline to 36 months
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Tear film stability will be assessed using non-invasive tear break-up time (NIBUT) measured with the LacryDiag ocular surface analyzer, a non-contact diagnostic device that evaluates tear film dynamics using Placido ring-based corneal topography. Higher values indicate greater tear film stability. Unit : seconds |
Baseline to 36 months
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Lipid Layer Thickness (LLT) Grade
Periodo de tiempo: Baseline to 36 months
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Lipid layer thickness (LLT) will be assessed using interferometry with the LacryDiag ocular surface analyzer.
LLT is recorded using a semi-quantitative grading scale ranging from 0 to 7 based on interferometric patterns of the tear film lipid layer.
Higher grades indicate a thicker lipid layer and improved tear film stability.
Scale Range 0-7
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Baseline to 36 months
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Tear Meniscus Height (TMH)
Periodo de tiempo: Baseline to 36 months
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Tear meniscus height (TMH) will be measured using the LacryDiag ocular surface analyzer.
TMH is an objective measure of tear volume obtained from infrared imaging of the lower tear meniscus.
Higher values indicate greater tear volume.
Unit : Millimeters (mm)
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Baseline to 36 months
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Meibomian Gland Dropout Percentage
Periodo de tiempo: Baseline to 36 months
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Meibomian gland dropout will be assessed using infrared meibography obtained with the LacryDiag ocular surface analyzer.
The proportion of meibomian gland loss within the tarsal area will be automatically calculated by the device and expressed as a percentage.
Higher percentages indicate greater meibomian gland loss and a worse outcome.
Unit : Percent (%)
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Baseline to 36 months
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Meibomian Gland Morphological Abnormality Score
Periodo de tiempo: Baseline to 36 months
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Meibomian gland morphology will be assessed using infrared meibography obtained with the LacryDiag ocular surface analyzer.
Four morphological abnormalities will be evaluated: tortuosity, shortening, overlapping, and hooked glands.
Each abnormality will be recorded as present or absent using a binary scoring system.
The total morphological abnormality score will range from 0 to 4, with higher scores indicating a greater number of meibomian gland morphological abnormalities and a worse outcome.
Scale range : 0-4
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Baseline to 36 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amarilla Barcsay-Veres, MD, Semmelweis University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NNGYK/23414-1/2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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