Cord Blood Platelet Poor Plasma Eye Drops

Not Applicable

Recruiting

• Conditions: Dry Eye

• Registration Number: NCT07089511
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-11
• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-21
• Study First Posted: 2025-07-28
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining	month 2	The difference in the mean change from baseline in the corneal and conjunctival staining (CFS) score at the 2-month visit between the two arms.

Trial Locations

Locations (1)

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy