Neurotrophic Keratopathy
Conditions
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.
Interventions
DRUGCord Blood Eye Drops
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
DRUGConventional treatment
1. Artificial tears: Lubristil ® 2. Therapeutic Contact lens: Air Optix Night&Day
Sponsors
Banc de Sang i Teixits
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal lesion size | after 3 weeks post-treatment, | Variation percentage in corneal lesion size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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) |
Countries
Spain
Outcome results
None listed