The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment

Personalized Approach in the Treatment of Patients Affected by Severe Dry Eye Associated With Therapy With EGFR Inhibitors (EGRFR-I) With Growth Factors in Cord Blood Serum (CBS) Eye Drops

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06830551

Enrollment

Registered

2025-02-17

Start date

2023-09-12

Completion date

2025-12-31

Last updated

2025-02-17

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

Conditions

Dry Eye

Brief summary

The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.

Detailed description

Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage. The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.

Interventions

DRUGadministration cord blood based eye drops, standardized to the deliver BDNF.

administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age over 18 years * oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs * signing of informed consent

Exclusion criteria

* Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.

Design outcomes

Primary

Measure	Time frame	Description
Corneal damage measured with National Eye Institute (NEI) score	one week before the start of treatment and thirty days after the end of treatment.	Evaluation of the effect of cord blood eye drops administration on the variation of corneal damage in patients with severe keratopathy

Secondary

Measure	Time frame	Description
Change in discomfort	one week before the start of treatment and thirty days after the end of treatment.	Symptomatology assessment with OSDI questionnaire. Quality of life analysis with Health-related SF-12 questionnaire, and SEI-QoL subjects' quality of life scale.
Change in quality of life	one week before the start of treatment and thirty days after the end of treatment.	Change in QOL measured by SF-12 questionnaire

Countries

Italy

Contacts

Primary ContactLuigi Fontana, MD

luigi.fontana6@unibo.it+390512142837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026