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

NCT03084861 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-10-27

No results posted yet for this study

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).

Conditions

  • Neurotrophic Keratopathy

Interventions

DRUG

Cord Blood Eye Drops

Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives

DRUG

Conventional treatment

1. Artificial tears: Lubristil ® 2. Therapeutic Contact lens: Air Optix Night\&Day

Sponsors & Collaborators

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Sergi Querol Giner, MD PHD · Banc de Sang i Teixits

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2020-03-12
Completion
2020-03-12

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084861 on ClinicalTrials.gov