Ocular Surface AllergyNCT07732855
Treatment of Ocular Surface Inflammations
An observational study of Ocular Surface Allergy and Conjunctivitis, Allergic, run by Semmelweis University at 1 site in Hungary.
Trial 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%. Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Ocular Surface Allergy, Conjunctivitis, Allergic, Blepharoconjunctivitis
- What is being tested?
- Topical Cyclosporine 1%
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 10 Jun 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- ocular surface inflammatory disease cornea inflammation -keratitis
Who cannot join
- eye surgery within 1 year, lack of fitness for the objective ocular surface measurments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Department of Ophthalmology
Budapest, Pest County, 1085
Amarilla Barcsay-Veres, MD.PhD., 003614591500, veres.amarilla@semmelweis.hu
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Topical Cyclosporine 1%
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Cyclosporine 1%Drug
Dosage may differ from severe dry eye indication
| Study group | Role | What they receive |
|---|---|---|
| Chronic ocular allergic inflammation | Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation Receives: Drug: Topical Cyclosporine 1% | |
| Blepharokeratoconjunctivitis | Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well Receives: Drug: Topical Cyclosporine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 36 months
Frequency of Rescue Steroid Use
Number of rescue topical corticosteroid treatments required during the study period.
Measured: 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.
Measured: Baseline to 36 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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)
Measured: 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 (%)
Measured: 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
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start10 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface AllergyStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luhyoun Lim, Semmelweis University
- Investigators
- Amarilla Barcsay-Veres, MD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732855
- Sponsor's protocol ID
- NNGYK/23414-1/2025
- Status last verified
- Jul 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ocular Surface Inflammations With 1% Cyclosporine (Ikervis) Eye Drops
- ClinicalTrials.gov ID
- NCT07732855
- Acronym / sponsor ID
- NNGYK/23414-1/2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic ocular allergic inflammation | – | Drug: Topical Cyclosporine 1%Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation |
| Blepharokeratoconjunctivitis | – | Drug: Topical Cyclosporine 1%Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- ocular surface inflammatory disease cornea inflammation -keratitis
Key exclusion criteria (1 listed)
- eye surgery within 1 year, lack of fitness for the objective ocular surface measurments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Cyclosporine 1%Dosage may differ from severe dry eye indication | Drug | Blepharokeratoconjunctivitis, Chronic ocular allergic inflammation |
Primary outcome
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).
Frequency of Rescue Steroid Use
Time frame: Baseline to 36 months
Number of rescue topical corticosteroid treatments required during the study period.
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.
5 secondary outcomes
Non-Invasive Tear Break-Up Time (NIBUT)
Time frame: Baseline to 36 months
Lipid Layer Thickness (LLT) Grade
Time frame: Baseline to 36 months
Tear Meniscus Height (TMH)
Time frame: Baseline to 36 months
Meibomian Gland Dropout Percentage
Time frame: Baseline to 36 months
Meibomian Gland Morphological Abnormality Score
Time frame: Baseline to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Ocular Surface Allergy
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Active, not recruitingObservational study
OJO-miR: microRNA Expression in Allergic Conjunctivitis.
Conjunctivitis, Allergic
Not yet recruitingPhase 1
Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis
Probiotic, Ocular Surface Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amarilla Barcsay-Veres, MD principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Surface Allergy and Conjunctivitis, Allergic, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lim Lu Hyoun (+3614591500, luhyoun21c@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective ocular symptoms (time frame: Baseline to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.