Actively Recruiting
Cord Blood Platelet Poor Plasma Eye Drops for Moderate to Severe Dry Eye Disease Treatment
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-09-08
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Dry eye disease (DED) is a common eye condition that disrupts the balance of the eye's surface, often causing discomfort and affecting quality of life. This condition particularly impacts women and older adults, with around 30 million adults in the US experiencing symptoms. Traditional treatment with artificial tears is often insufficient for moderate to severe cases linked to corneal inflammation. Researchers are conducting a randomized clinical trial to compare the effectiveness of umbilical cord blood platelet poor plasma eye drops against artificial tears in treating moderate to severe DED. Participants in this study will be randomly assigned to receive either a combination of umbilical cord blood platelet poor plasma eye drops and 0.1% cyclosporine eye drops, or a combination of 0.15% hyaluronic acid and 0.1% cyclosporine eye drops. The study is double-blind, meaning neither the participants nor the researchers know who receives which treatment during the trial. This design aims to rigorously evaluate the safety and clinical effects of these treatments over the course of the study. During the trial, participants will undergo scheduled examinations and assessments including corneal fluorescein staining to measure eye surface damage at two months. They will need to have had at least three months of conventional treatment for DED before joining, and they will be monitored closely to evaluate treatment effects and any side effects. The study will continue until August 2026, with careful attention to participant adherence, safety, and detailed eye health evaluations throughout the trial period.
CONDITIONS
Brief 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
- Schirmer test score less than 10 mm/5 min or Ocular Surface Disease Index score of at least 30 or presence of at least two moderate to severe dry eye symptoms
- Ability to understand and comply with study requirements
- Signed informed consent and privacy authorization
- At least 3 months of prior treatment with cyclosporine and/or hyaluronic acid for dry eye
- 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 prior to baseline
- Any ocular disease other than dry eye requiring treatment during study
- Ocular rosacea or severe blepharitis
- Progressive pterygium
- Concurrent ocular allergy or chronic conjunctivitis other than dry eye
- Planned insertion of temporary punctal plugs during study
- Best corrected visual acuity 0.1 or worse in either eye
- Unstable systemic disease within 30 days of baseline
- Severe systemic allergy history
- Known hypersensitivity to study products or components
- History of ocular or other malignancy within 5 years
- Recent or anticipated dosage changes in systemic medications affecting dry eye
- Changes in systemic immunosuppressive therapy within 30 days prior or during study
- History of substance abuse or alcohol dependence
- Any disorder interfering with study procedures or results
- Pregnancy or breastfeeding at baseline
- Women of childbearing potential unwilling to use effective contraception
- Participation in other clinical trials within 30 days prior or concurrent with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants receive two different eye drop combinations in a crossover design to treat moderate to severe dry eye disease.
Multiple visits during treatment periods as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
Research Team
F
FRANCESCO VIOLA
C
CLAUDIA MAINETTI
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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