Autologous Platelet Lysate in Corneal Epithelial Defects

The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02979912

Enrollment

Registered

2016-12-02

Start date

2017-02-16

Completion date

2019-01-30

Last updated

2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Corneal Epithelial Defect

Keywords

Persistent corneal epithelial defect, Platelet Lysate

Brief summary

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

Detailed description

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.

Interventions

BIOLOGICALPlatelet Lysate

Eye drops of Platelet Lysate

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 78 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops	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

Measure	Time frame	Description
Assessment of the efficacy by clinical judgment	6 months	Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026