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Treatment of Ocular Surface Inflammations

2026年7月31日 更新者：Luhyoun Lim、Semmelweis University

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 匈牙利
    • Pest County
      • Budapest、Pest County、匈牙利、1085
        • 招聘中
        • Semmelweis University Department of Ophthalmology
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Chronic ocular allergic inflammation
Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation
药品：Topical Cyclosporine 1%
Dosage may differ from severe dry eye indication
Blepharokeratoconjunctivitis
Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well
药品：Topical Cyclosporine 1%
Dosage may differ from severe dry eye indication

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
subjective ocular symptoms
大体时间：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).
Baseline to 36 months
Frequency of Rescue Steroid Use
大体时间：Baseline to 36 months
Number of rescue topical corticosteroid treatments required during the study period.
Baseline to 36 months
Oxford Grading Scale Score for Ocular Surface Staining
大体时间：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.
Baseline to 36 months

次要结果测量

结果测量
措施说明
大体时间
Non-Invasive Tear Break-Up Time (NIBUT)
大体时间：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
Baseline to 36 months
Lipid Layer Thickness (LLT) Grade
大体时间：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
Baseline to 36 months
Tear Meniscus Height (TMH)
大体时间：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)
Baseline to 36 months
Meibomian Gland Dropout Percentage
大体时间：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 (%)
Baseline to 36 months
Meibomian Gland Morphological Abnormality Score
大体时间：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
Baseline to 36 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Semmelweis University

调查人员

  • 首席研究员：Amarilla Barcsay-Veres, MD、Semmelweis University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月10日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NNGYK/23414-1/2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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