Treatment of Ocular Surface Inflammations

NCT07732855 | Recruiting

• 1 other identifier: NNGYK/23414-1/2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Surface Allergy; Conjunctivitis, Allergic; Blepharoconjunctivitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Non-Invasive Tear Break-Up Time (NIBUT)

  Baseline to 36 months

• Lipid Layer Thickness (LLT) Grade

  Baseline to 36 months

• Tear Meniscus Height (TMH)

  Baseline to 36 months

• Meibomian Gland Dropout Percentage

  Baseline to 36 months

• Meibomian Gland Morphological Abnormality Score

  Baseline to 36 months

Study Arms (2)

Chronic ocular allergic inflammation

Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation

Drug: Topical Cyclosporine 1%

Blepharokeratoconjunctivitis

Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well

Drug: Topical Cyclosporine 1%

Interventions

Topical Cyclosporine 1% DRUG

Dosage may differ from severe dry eye indication

Blepharokeratoconjunctivitis; Chronic ocular allergic inflammation

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• ocular surface inflammatory disease cornea inflammation -keratitis

You may not qualify if:

• eye surgery within 1 year, lack of fitness for the objective ocular surface measurments

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Department of Ophthalmology

Budapest, Pest County, 1085, Hungary

RECRUITING

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Amarilla Barcsay-Veres, MD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lim Lu Hyoun

CONTACT

+3614591500; luhyoun21c@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: July 29, 2026
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-06

Locations

HU (1)