EUCTR2019-000982-19-ES进行中（未招募）1 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 de Oftalmobiología Aplicada (IOBA)0 个研究点目标入组 25 人开始时间: 2019年10月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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.
研究者
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