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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2021 |
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Main ID: |
NCT02979912 |
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Date of registration:
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29/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Autologous Platelet Lysate in Corneal Epithelial Defects
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Scientific title:
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The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects |
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Date of first enrolment:
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February 16, 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02979912 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Abdallah Awidi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cell Therapy Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Cognitive ability to understand and sign the consent form.
2. Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment
(therapeutic contact lenses, topical artificial tears, eye packs and antibiotic
eye-drops).
3. Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy,
corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal
lesions due to a foreign body.
4. Good compliance with the study regimen and availability for the duration of the entire
study period.
Exclusion Criteria:
1. Corneal ulcers which developed tissue scars.
2. Pregnant or lactating women.
Age minimum:
21 Years
Age maximum:
78 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Persistent Corneal Epithelial Defect
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Intervention(s)
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Biological: Platelet Lysate
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Primary Outcome(s)
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops
[Time Frame: 2 months]
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Secondary Outcome(s)
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Assessment of the efficacy by clinical judgment
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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