NCT04492878已完成4 期
A Phase IV Open-Label Clinical Trial to Evaluate the Efficacy of Ikervis® on Clinical Parameters and Molecular/Cellular Biomarkers in Dry Eye Patients With Severe Keratitis Who Have Not Improved Despite Regular Use of Tear Substitutes Before and After Exposure to an Adverse Controlled Environment
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年2月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Corneal fluoresceing staining
研究概览
简要总结
The proposed study is a prospective, open-label, unicentric, phase IV clinical trial.
This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Additionally, this study intends to investigate whether IKERVIS® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ACE) and analyzing both clinical and molecular parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Diagnosis of DED with Severe Keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously.
- •Not stable (as defined by the two items below) under at least 2 months of constant and regular use of artificial tears (at least 4 drops a day)
- •Fluorescein corneal staining ≥ 2 (Oxford scale) in both eyes.
- •DEQ-5 > 6 points
- •Use of at least 4 times daily of an ocular artificial tears.
- •Any concomitant medication that may affect DED, ocular surface condition or vision, must have a start date at least 3 months prior to baseline and dosage is not expected to change during the study.
- •Best corrected visual acuity (BCVA) of at least 0.1 logMar at 6 meters with each eye.
- •Signature of written informed consent form and data protection form.
排除标准
- •Known allergy or sensitivity to the study product(s) or its components.
- •Any ocular pathology other than DED.
- •History of severe ocular inflammation other than that due to DED or infection in the 6 previous months to the study inclusion.
- •Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months or any ocular or systemic surgery or procedure planned during the study duration that may affect the study as assessed by principal investigator.
- •History of refractive surgery in the previous 18 months.
- •Contact lens use in the ONE previous month to study inclusion and during the duration of the study.
- •Use of any ocular topical medication for pathologies other than DED.
- •Use of any other ocular topical medication for DED other than artificial tears during the last ONE (steroids) or THREE months (ciclosporine, tacrolimus) .
- •Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren's syndrome)
- •The start date of any systemic medication that may affect DED, ocular surface condition or vision is < 3 months prior to baseline or a change in dosage is anticipated during the study.
- •Occlusion of the lacrimal puncta either surgically or with plugs within one month prior to study, or anticipated use of the same during the study.
- •Pregnancy or breastfeeding.
- •Current enrolments in an investigational drug or device study or participation in such a study within 30 day of entry into this study at baseline.
研究组 & 干预措施
IKERVIS® (1mg/mL ciclosporin) eye drops
Experimental
干预措施: IKERVIS®1mg/mL (Drug)
结局指标
主要结局
Corneal fluoresceing staining
时间窗: V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment); V2 (30 days of treatment) vs V3 (90 days of treatment)
Significant reduction in corneal fluorescein staining
次要结局
- Response against adverse environmental conditions(V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment))
- Molecular changes(V1 (baseline) vs V2 (30 days of treatment); V1 (baseline) vs V3 (90 days of treatment))
研究者
研究点 (1)
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