se of umbilical cord eye drops in neurotrophic keratopathy

Phase 1

• Conditions: eurotrophic Keratitis, stage 2 or 3; MedDRA version: 19.0Level: PTClassification code 10064996Term: Ulcerative keratitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-001841-23-ES
• Lead Sponsor: Banc de Sang i Teixits

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-19
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of cord blood eye drops in Neurotrophic Keratitis treatment by changes in lesion size observed by slit lamp after 3 weeks of treatment.;Secondary Objective: -To assess the safety of cord blood eye drops in Neurotrophic Keratitis treatment.<br>-To assess the efficacy of cord blood eye drops in Neurotrophic Keratitis treatment by changes in lesion size observed by slit lamp after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.<br>-To assess the corneal sensibility after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.<br>-To assess the corneal opacity by slit lamp after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.<br>-To assess the visual acuity after 2-3 days of treatment and at 1, 2, 3 and 6 weeks.<br>-To assess the Neurotrophic Keratitis complications per treatment group.;Primary end point(s): -Variation percentage in corneal lesion size after 3 weeks post-treatment, per treatment group;Timepoint(s) of evaluation of this end point: after 3 weeks post-treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Safety evaluation through laboratory data and adverse events, per treatment group.<br>-Variation percentage in corneal lesion size at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment, per treatment group.<br>-Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline, at 3 weeks post-treatment.<br>-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.<br>-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.<br>-Line variation in relation to visual acuity at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment.<br>-Number of NK complications per treatment group.;Timepoint(s) of evaluation of this end point: 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment.