Treatment of Ocular Surface Inflammations
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-60
SponsorSemmelweis University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ocular surface inflammatory disease cornea inflammation -keratitis
Disqualifiers
eye surgery within 1 year, lack of fitness for the objective ocular surface measurments
Trial population
Patients with chronic ocular surface inflammation are involved and followed. Patients older than 4 years and younger than 60 years are involved. Women and men are involved , all types of rasses are involved.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Topical Cyclosporine 1%
DrugDosage may differ from severe dry eye indication
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Chronic ocular allergic inflammation1 intervention
Group B: Blepharokeratoconjunctivitis1 intervention
Trial outcomes
Primary outcomes
1
subjective ocular symptoms
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).
Time frame
Baseline to 36 months2
Frequency of Rescue Steroid Use
Number of rescue topical corticosteroid treatments required during the study period.
Time frame
Baseline to 36 months3
Oxford Grading Scale Score for Ocular Surface Staining
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.
Time frame
Baseline to 36 monthsSecondary outcomes
1
Non-Invasive Tear Break-Up Time (NIBUT)
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
Time frame
Baseline to 36 months2
Lipid Layer Thickness (LLT) Grade
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
Time frame
Baseline to 36 months3
Tear Meniscus Height (TMH)
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)
Time frame
Baseline to 36 months4
Meibomian Gland Dropout Percentage
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 (%)
Time frame
Baseline to 36 monthsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Semmelweis University Department of OphthalmologyRecruiting1085, Budapest, Pest County
Hungary
HungarySponsors and contacts
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Source ClinicalTrials.gov