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

Neurotrophic Keratopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03084861
• Other study ID #: I.2016.010
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 24, 2017
• Est. completion date: March 12, 2020

Study information

• Verified date: October 2020
• Source: Banc de Sang i Teixits
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurotrophic Keratopathy

Intervention

Drug:
• Cord Blood Eye Drops
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
• Conventional treatment
Artificial tears: Lubristil ® Therapeutic Contact lens: Air Optix Night&Day

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital de l'Esperança	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia
Spain	Hospital Vall d'Hebron	Barcelona	Catalonia
Spain	Institut de microcirurgia ocular IMO	Barcelona
Spain	Instituto Oftalmológico Quirónsalud Barcelona	Barcelona
Spain	Hospital Josep Trueta	Girona
Spain	Hospital Joan XXIII	Tarragona
Spain	Hospital Mútua de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Banc de Sang i Teixits

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal lesion size	Variation percentage in corneal lesion size	after 3 weeks post-treatment,
Secondary	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)
Secondary	Corneal lesion size	Variation percentage in corneal lesion size	at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Visual acuity	Line variation in relation to visual acuity	at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
Secondary	Neurotrophic keratopathy	Number of neurotrophic keratopathy complications	From date of randomization until the date of the last visit (6 weeks post-treatment)