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NCT Number: NCT07732855

Treatment of Ocular Surface Inflammations

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.

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Key information

Conditions

Ocular Surface Allergy Blepharoconjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

4 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University Department of Ophthalmology

Budapest, Pest County, 1085, Hungary

Location status: Recruiting

Location contact

Amarilla Barcsay-Veres, MD.PhD.

CONTACT

[email protected]

003614591500

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Cyclosporine 1%

Drug

Dosage may differ from severe dry eye indication

Primary outcomes

  1. 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).

  2. Frequency of Rescue Steroid Use

    Time frame: Baseline to 36 months

    Number of rescue topical corticosteroid treatments required during the study period.

  3. 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

  1. Non-Invasive Tear Break-Up Time (NIBUT)

    Time frame: 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

  2. Lipid Layer Thickness (LLT) Grade

    Time frame: 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

  3. Tear Meniscus Height (TMH)

    Time frame: 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)

  4. Meibomian Gland Dropout Percentage

    Time frame: 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 (%)

  5. Meibomian Gland Morphological Abnormality Score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lim Lu Hyoun

CONTACT

[email protected]

+3614591500

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Treatment of Ocular Surface Inflammations With 1% Cyclosporine (Ikervis) Eye Drops

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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