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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Lim Lu Hyoun
- Telefonnummer: +3614591500
- E-mail: luhyoun21c@gmail.com
Studiesteder
-
-
Pest County
-
Budapest, Pest County, Ungarn, 1085
- Rekruttering
- Semmelweis University Department of Ophthalmology
-
Kontakt:
- Amarilla Barcsay-Veres, MD.PhD.
- Telefonnummer: 003614591500
- E-mail: veres.amarilla@semmelweis.hu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Chronic ocular allergic inflammation
Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation
|
Dosage may differ from severe dry eye indication
|
|
Blepharokeratoconjunctivitis
Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well
|
Dosage may differ from severe dry eye indication
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
subjective ocular symptoms
Tidsramme: 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).
|
Baseline to 36 months
|
|
Frequency of Rescue Steroid Use
Tidsramme: Baseline to 36 months
|
Number of rescue topical corticosteroid treatments required during the study period.
|
Baseline to 36 months
|
|
Oxford Grading Scale Score for Ocular Surface Staining
Tidsramme: 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.
|
Baseline to 36 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Non-Invasive Tear Break-Up Time (NIBUT)
Tidsramme: Baseline to 36 months
|
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
|
|
Lipid Layer Thickness (LLT) Grade
Tidsramme: Baseline to 36 months
|
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
|
Baseline to 36 months
|
|
Tear Meniscus Height (TMH)
Tidsramme: Baseline to 36 months
|
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)
|
Baseline to 36 months
|
|
Meibomian Gland Dropout Percentage
Tidsramme: Baseline to 36 months
|
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 (%)
|
Baseline to 36 months
|
|
Meibomian Gland Morphological Abnormality Score
Tidsramme: Baseline to 36 months
|
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
|
Baseline to 36 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Amarilla Barcsay-Veres, MD, Semmelweis University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NNGYK/23414-1/2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .