A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neurotrophic Keratopathy

Intervention / Treatment
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* Drug: Cord Blood Eye Drops
* Drug: Conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cord blood eye drops<br>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 | Drug: Cord Blood Eye Drops<br>* Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives<br>|
| Active Comparator: Conventional treatment<br>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 | Drug: Conventional treatment<br>* Artificial tears: Lubristil ® Therapeutic Contact lens: Air Optix Night&Day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal lesion size | Variation percentage in corneal lesion size | after 3 weeks post-treatment, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Safety evaluation through laboratory data and adverse events | From date of randomization until the date of the last visit (6 weeks post-treatment) | 
| Corneal lesion size | Variation percentage in corneal lesion size | at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment | 
| Stage on the corneal lesion | Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline | at 3 weeks post-treatment | 
| Qualitative scale of corneal sensibility | Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia) | at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment | 
| Corneal opacity | Changes on corneal opacity from baseline (not response, improvement, worse) | at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment | 
| Visual acuity | Line variation in relation to visual acuity | at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment | 
| Neurotrophic keratopathy | Number of neurotrophic keratopathy complications | From date of randomization until the date of the last visit (6 weeks post-treatment) |