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Cord Blood Platelet Poor Plasma Eye Drops

NCT07089511 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-08

No results posted yet for this study

Summary

Dry eye disease (DED) is a prevalent ocular condition characterized by the disruption of the ocular surface's homeostasis. It affects a significant portion of the population, particularly women and older individuals. The impact of DED on the healthcare system and patients' quality of life is substantial, with approximately 30 million adult patients (14.5%) reporting DED symptoms in the US. Global mapping studies have shown that DED prevalence ranges from 5% to 50% of the population. While chronic instillation of artificial tears is the main treatment strategy for DED, it is often ineffective in moderate to severe cases associated with corneal inflammation.

Innovative therapeutic approaches using human serum and platelet derivatives have shown promising results in tear substitution. Umbilical cord blood plasma, which contains natural tissue regenerative and immunomodulatory factors, has demonstrated positive effects on corneal epithelial cells and clinical efficacy in observational studies. This study aims to develop a randomized clinical trial protocol to compare the clinical efficacy of artificial tears (control arm) and human platelet poor plasma from umbilical cord blood (treatment arm) in the treatment of DED.

The results of this clinical trial will contribute to understanding the clinical efficacy of umbilical cord blood plasma eye drops compared to artificial tears in the treatment of moderate to severe DED.

Conditions

  • Dry Eye

Interventions

OTHER

CB3P-ED + 0.1% cyclosporine eye drops

Combination of CB3P-ED + 0.1% cyclosporine eye drops

OTHER

0.15% hyaluronic acid + 0.1% cyclosporine eye drops

Combination of 0.15% hyaluronic acid + 0.1% cyclosporine eye drops

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Francesco Viola, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089511 on ClinicalTrials.gov