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.

Study Overview

• Status: Recruiting
• Conditions: Conjunctivitis, Allergic; Blepharoconjunctivitis; Ocular Surface Allergy
• Intervention / Treatment: Drug: Topical Cyclosporine 1%

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Lim Lu Hyoun; Phone Number: +3614591500; Email: luhyoun21c@gmail.com

Study Locations

• Hungary
  • Pest County
    • Budapest, Pest County, Hungary, 1085
      • Recruiting
      • Semmelweis University Department of Ophthalmology
      • Contact: Amarilla Barcsay-Veres, MD.PhD.; Phone Number: 003614591500; Email: veres.amarilla@semmelweis.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic ocular allergic inflammation; Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation	Drug: Topical Cyclosporine 1%; Dosage may differ from severe dry eye indication
Blepharokeratoconjunctivitis; Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well	Drug: Topical Cyclosporine 1%; Dosage may differ from severe dry eye indication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to 36 months
Frequency of Rescue Steroid Use	Number of rescue topical corticosteroid treatments required during the study period.	Baseline to 36 months
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.	Baseline to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 36 months
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	Baseline to 36 months
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)	Baseline to 36 months
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 (%)	Baseline to 36 months
Meibomian Gland Morphological Abnormality Score	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

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Amarilla Barcsay-Veres, MD, Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Conjunctivitis; Conjunctival Diseases; Conjunctivitis, Allergic
• Other Study ID Numbers: NNGYK/23414-1/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No