Actively Recruiting
Cord Blood Platelet Poor Plasma Eye Drops
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-09-08
100
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Cord Blood Platelet Poor Plasma Eye Drops
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male or female
- Diagnosis of Dry Eye Disease with severe keratitis and ocular discomfort
- Corneal Fluorescein Staining score of 3, 4, or 5 on the modified Oxford scale in at least one eye at baseline
- Schirmer test without anesthesia less than 10 mm/5 min in the same eye at baseline OR Ocular Surface Disease Index score at least 30, or at least two moderate to severe dry eye symptoms with severity above 50 at baseline
- Ability to understand and comply with study requirements
- Provide written informed consent and privacy authorization
- At least 3 months of prior treatment with cyclosporine 1 mg/ml and/or hyaluronic acid
- Willingness and ability to attend all scheduled visits and examinations
You will not qualify if you...
- Active herpetic keratitis or history of ocular herpes
- Ocular trauma or infection within 90 days before baseline
- Any ocular disease other than dry eye requiring topical treatment during study
- Ocular rosacea and/or severe blepharitis
- Progressive pterygium
- Concurrent ocular allergy or chronic conjunctivitis other than dry eye
- Planned temporary punctal plugs insertion during study
- Best corrected visual acuity 0.1 or worse in either eye
- Unstable systemic disease within 30 days before baseline or conditions incompatible with study
- Severe systemic allergy history
- Known hypersensitivity to study products or their components
- History of ocular malignancy
- History of non-ocular malignancy within last 5 years
- Changes in systemic medications affecting dry eye within 30 days before baseline or expected during study
- Changes in systemic immunosuppressive therapy within 30 days before baseline or expected during study
- History of substance abuse or alcohol dependence
- Any systemic or ocular disorder interfering with study procedures or results
- Pregnancy or breastfeeding at baseline
- Women of childbearing potential unwilling to use effective contraception during treatment and 2 weeks after
- Participation in other investigational clinical trial within 30 days before baseline
- Concurrent participation in another clinical trial during this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
Research Team
F
FRANCESCO VIOLA
CONTACT
C
CLAUDIA MAINETTI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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