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

Not Applicable

Recruiting

• Conditions: Dry Eye
• Interventions: Drug: administration cord blood based eye drops, standardized to the deliver BDNF.

• Registration Number: NCT06830551
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2023-09-12
• Status Verified: 2024-11
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eye drops derived from cordonal blood serum	administration cord blood based eye drops, standardized to the deliver BDNF.	patients who are given eye drops

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 SEI-QoL questionnaire
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.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy