NCT07089511

Cord Blood Platelet Poor Plasma Eye Drops

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-03-11
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-07-28
• Last updated: 2025-09-08

Locations

1 site across 1 country: Italy