A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
- Conditions
- Neurotrophic Keratopathy
- Interventions
- Drug: Cord Blood Eye DropsDrug: Conventional treatment
- Registration Number
- NCT03084861
- Lead Sponsor
- Banc de Sang i Teixits
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cord blood eye drops 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 Conventional treatment Conventional treatment Conventional treatment: 1. 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 2. 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
- Primary Outcome Measures
Name Time Method Corneal lesion size after 3 weeks post-treatment, Variation percentage in corneal lesion size
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events From date of randomization until the date of the last visit (6 weeks post-treatment) Safety evaluation through laboratory data and adverse events
Corneal lesion size at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment Variation percentage in corneal lesion size
Stage on the corneal lesion at 3 weeks post-treatment Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline
Qualitative scale of corneal sensibility at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia)
Corneal opacity at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment Changes on corneal opacity from baseline (not response, improvement, worse)
Visual acuity at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment Line variation in relation to visual acuity
Neurotrophic keratopathy From date of randomization until the date of the last visit (6 weeks post-treatment) Number of neurotrophic keratopathy complications
Trial Locations
- Locations (10)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Catalonia, Spain
Hospital Joan XXIII
🇪🇸Tarragona, Spain
Institut de microcirurgia ocular IMO
🇪🇸Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital de l'Esperança
🇪🇸Barcelona, Spain
Instituto Oftalmológico Quirónsalud Barcelona
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Catalonia, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Josep Trueta
🇪🇸Girona, Spain
Hospital Mútua de Terrassa
🇪🇸Terrassa, Barcelona, Spain