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NCT Number: NCT06830551

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Luigi Fontana, MD

CONTACT

[email protected]

+390512142837

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Corneal damage measured with National Eye Institute (NEI) score

    Time frame: 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 outcomes

  1. Change in discomfort

    Time frame: 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.

  2. Change in quality of life

    Time frame: one week before the start of treatment and thirty days after the end of treatment.

    Change in QOL measured by SF-12 questionnaire

  3. Change in quality of life

    Time frame: one week before the start of treatment and thirty days after the end of treatment.

    Change in QOL measured by SEI-QoL questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Fontana, MD

CONTACT

[email protected]

+390512142837

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

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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