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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 10
- 主要终点
- Corneal lesion size
研究概览
简要总结
This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).
详细描述
This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of NK. Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).
All patients, with conventional or experimental treatment, will be treated for 19 days. A topical antibiotic will be added too as a concomitant treatment to all treatment groups, until the injury closes or according to medical criteria.
After signing informed consent, inclusion and exclusion criteria will be assessed, and if the patient meets all the requirements, the patient will be randomized.
After initiation of the treatment, patients will be follow-up at 2-3 days and once a week for 3 weeks. A final follow-up is planned at 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 old
- •NK stage 2 or 3 (Mackie classification)
- •Signed Informed Consent Form
- •The patient is able to understand the nature of the study and to participate throughout its duration
排除标准
- •Medical history of eye tumors
- •Active eye infection
- •Eyelid bad position or eyelid closure problems
- •Conjunctiva scarring
- •Topic chronic eye treatments with corticoids
- •Acute corneal burns (<3 months)
- •Intolerance to contact lens
- •Allergy or inability to receive concomitant treatment with Exocin®
- •Patients with immunosuppressive or chemotherapy treatment
- •Pregnant woman or woman without proper contraceptive methods according to the investigator (*), or lactating women
- •Participation in another clinical trial in the last month (*) Contraceptive methods accepted in the protocol are: hormonal, intrauterine device (IUD), barrier methods, voluntary sterilization or the patient has menopause >1 year duration
研究组 & 干预措施
cord blood eye drops
Experimental drug: cord blood eye drops Description: eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 19 vials of 1 mL per vial Route of administration: ophthalmic/ocular
干预措施: Cord Blood Eye Drops (Drug)
Conventional treatment
Conventional treatment:
- Artificial tears Description: Lubristil ® (single dose) Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 20 or 30 vials of 0.3 mL per vial Route of administration: ophthalmic
- Therapeutic Contact lens Description: Air Optix Night&Day Dosage regimen: 1 contact lens per visit Pharmaceutical form: contact lens Presentation: 1 unit per case Route of administration: ophthalmic/ocular
干预措施: Conventional treatment (Drug)
结局指标
主要结局
Corneal lesion size
时间窗: after 3 weeks post-treatment,
Variation percentage in corneal lesion size
次要结局
- Incidence of Adverse Events(From date of randomization until the date of the last visit (6 weeks post-treatment))
- Corneal lesion size(at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment)
- Stage on the corneal lesion(at 3 weeks post-treatment)
- Qualitative scale of corneal sensibility(at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment)
- Corneal opacity(at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment)
- Visual acuity(at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment)
- Neurotrophic keratopathy(From date of randomization until the date of the last visit (6 weeks post-treatment))