EUCTR2016-001841-23-ES进行中（未招募）1 期
A multicenter, randomized, open-label, two-arms phase I/II clinical trial to asses efficacy and safety of cord blood eye drops in neurotrophic keratopathy - Use of umbilical cord eye drops in neurotrophic keratopathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •1. Age = 18 years old
- •2. NK stage 2 or 3 (Mackie classification)
- •3. Signed Informed Consent Form
- •4. The patient is able to understand the nature of the study and to participate throughout its duration
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Medical history of eye tumors
- •2. Active eye infection
- •3. Eyelid bad position or eyelid closure problems
- •4. Conjunctiva scarring
- •5. Topic chronic eye treatments with corticoids
- •6. Acute corneal burns (<3 months)
- •7. Intolerance to contact lens
- •8. Allergy or inability to receive concomitant treatment with Exocin®
- •9. Patients with immunosuppressive or chemotherapy treatment
- •10. Pregnant woman or woman without proper contraceptive methods according to the investigator, or lactating women
- •11. Participation in another clinical trial in the last month
研究者
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