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Completed

NCT Number: NCT02979912

Autologous Platelet Lysate in Corneal Epithelial Defects

Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.

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Key information

Conditions

Persistent Corneal Epithelial Defect

Age range

21 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cell Therapy Center

Amman, 11942, Jordan

About this study

Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cognitive ability to understand and sign the consent form.
  • 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).
  • 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.
  • Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion criteria

  • Corneal ulcers which developed tissue scars.
  • Pregnant or lactating women.

Treatment and study plan

Platelet lysate

Biological

Eye drops of Platelet Lysate

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops

    Time frame: 2 months

    Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.

Secondary outcomes

  1. Assessment of the efficacy by clinical judgment

    Time frame: 6 months

    Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect

Sponsors and collaborators

Lead sponsor

hanan Jafar

Unknown

Registry information

Official study title

The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2016
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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