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

Banc de Sang i Teixits

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Neurotrophic Keratopathy

Treatments: Drug: Cord Blood Eye Drops; Drug: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03084861

I.2016.010

Details and patient eligibility

About

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).

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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 (*) Contraceptive methods accepted in the protocol are: hormonal, intrauterine device (IUD), barrier methods, voluntary sterilization or the patient has menopause >1 year duration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

cord blood eye drops

Experimental group

Description:

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

Treatment:

Drug: Cord Blood Eye Drops

Conventional treatment

Active Comparator group

Description:

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

Treatment:

Drug: Conventional treatment