EUCTR2015-003326-13-ES进行中（未招募）不适用
Randomized, parallel groups, multicenter and blind to evaluators clinical trial, to evaluate the efficacy and safety of PRGF-Endoret eye drops, in patients with stage 2 and 3 neurotrophic keratitis. - PRGF-Endoret eye drops in Keratitis Neurotrófica
BTI Biotechnology Institute I mas D0 个研究点开始时间: 2015年11月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Patients aged 18 or over.
- •2. Patients with neurotrophic keratitis at stages 2 (persistent epithelial defect, PED) or 3 (corneal ulcer) affecting only one eye. Patients with the contralateral eye affected with NK at stage 1 could be included.
- •3. Persistent epithelial defect or corneal ulcer of at least 2 weeks duration resistant to one or more traditional non-surgical treatments for neurotrophic keratitis (as artificial tears, gels or ointments without preservatives; eye drops discontinuation and medicines for topical use with preservatives which may reduce corneal sensibility; therapeutic contact lenses).
- •4. Corneal sensitivity reduction test (using ?4 Cochet-Bonnet esthesiometer) in the area of the persistent epithelial defect or corneal ulcer and out of the defect area in at least one corneal quadrant.
- •5. No objective clinical evidence of improvement in the persistent epithelial defect or corneal ulcer in the two weeks prior to enrollment in the study.
- •6. Patients who have previously read and signed the informed consent.
- •7. Patients able and willing to comply with the study procedures.
- •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 76
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with neurotrophic keratitis stages 2 or 3 that affects both eyes.
- •2. With active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to the neurotrophic keratitis in the affected eye.
- •3. Any other eye disease that requires of topical ocular treatment in the affected eye during the course of the treatment period of the study.
- •4. Patients with severe vision loss in the affected eye with no chance of visual improvement (> 50% Wecker scale), in the investigator's opinion, as a result of study treatment.
- •5. Patients with severe blepharitis and/or severe Meibomian glands disease in the affected eye.
- •6. History of eye surgery (including surgical or refractive laser procedures) in the affected eye in the three months prior to enter the study (except when it is considered that the eye surgery is the cause of the neurotrophic keratitis stage 2 or 3), or patients who plan to undergo surgery.
- •7. Having received previously surgical procedures for the treatment of neurotrophic keratitis in the affected eye (eg complete tarsorrhaphy, conjunctival flap, etc.) with the exception of a transplant of the amniotic membrane (includable only two weeks after the disappearance of the membrane in the area of persistent epithelial defect or corneal ulcer, or at least six weeks after the date of the amniotic membrane transplant procedure). Patients previously treated with Botox injections (botulinum toxin) only if the last injection was administered at least 90 days prior to enrollment in the study.
- •8. Use of therapeutic contact lenses or for refractive correction during the periods of the study treatment in the affected eye.
- •9. Patients with punctual occlusion or insertion of punctual plugs previous to the study or with an anticipated need for punctual occlusion during the study time.
- •10. Evidence of corneal ulcer affecting the corneal stroma posterior third, fusion or cornea perforation in the affected eye.
- •11. Presence or history of any disorder or ocular or systemic disease that could limit the treatment effectiveness or its evaluation, which could interfere with the interpretation of the results or that the investigator could determine incompatible with the schedule of the study visits or with its realization (eg, corneal disorders or progressive or degenerative retinal, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases).
- •12. Any need of change (at that time or planned) in the dose of systemic drugs known to disrupt the functioning of the trigeminal nerve (eg, neuroleptics, antipsychotics, and antihistamines). These treatments will be allowed during the study if they were started before the 30 days prior to enrollment in the study, provided that they remain stable during the course of the study treatment periods.
- •13. Known hypersensitivity to any of the procedural compounds (eg. fluoresceine).
- •14. Presence of blood disorders related to platelet or clotting disorders, or who for whatever reason are receiving anticoagulants or antiplatelet agents.
- •15. Patients with a positive result in serological tests for syphilis, Hepatitis B, Hepatitis C or HIV I / II.
- •16. Patient in current treatment for their pathology already well managed.
- •17. Use of any investigational drug within 4 weeks prior to the screening visit.
- •18. Pregnant women or intended to be pregnant.
- •19. Participating in another clinical study while in this study.
研究者
相似试验
进行中（未招募）
1 期
A research study to find out if aprocitentan is efficacious and safe to treat difficult to control (resistant) high blood pressure (hypertension)Resistant HypertensionEUCTR2017-004393-33-NLIdorsia Pharmaceuticals Ltd600
进行中（未招募）
1 期
A research study to find out if aprocitentan is efficacious and safe to treat difficult to control (resistant) high blood pressure (hypertension)MedDRA version: 21.1Level: LLTClassification code 10020783Term: Hypertension not adequately controlledSystem Organ Class: 100000004866Resistant HypertensionEUCTR2017-004393-33-LTIdorsia Pharmaceuticals Ltd600
进行中（未招募）
1 期
A research study to find out if aprocitentan is efficacious and safe to treat difficult to control (resistant) high blood pressure (hypertension)MedDRA version: 20.0Level: LLTClassification code 10020783Term: Hypertension not adequately controlledSystem Organ Class: 100000004866Resistant HypertensionEUCTR2017-004393-33-ESIdorsia Pharmaceuticals Ltd730
进行中（未招募）
1 期
A research study to find out if aprocitentan is efficacious and safe to treat difficult to control (resistant) high blood pressure (hypertension)Resistant HypertensionMedDRA version: 21.1Level: LLTClassification code 10020783Term: Hypertension not adequately controlledSystem Organ Class: 100000004866EUCTR2017-004393-33-CZIdorsia Pharmaceuticals Ltd600
进行中（未招募）
1 期
A research study to find out if aprocitentan is efficacious and safe to treat difficult to control (resistant) high blood pressure (hypertension)MedDRA version: 21.1Level: LLTClassification code 10020783Term: Hypertension not adequately controlledSystem Organ Class: 100000004866Resistant HypertensionEUCTR2017-004393-33-GBIdorsia Pharmaceuticals Ltd600