CompletedNot Applicable

Cord Blood Platelet Poor Plasma Eye Drops

Italy101 participantsStarted 2025-03-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years.
. Male or female.
. Diagnosis of Dry Eye Disease (DED) with severe keratitis and ocular discomfort related to DED, defined as follows:
. Ability to understand and comply with the protocol requirements (as judged by the investigator).
. Provision of written informed consent and privacy authorization prior to initiation of any study procedures.
. At least 3 months of conventional treatment use (cyclosporine 1 mg/ml and/or hyaluronic acid) for DED prior to the Baseline Visit.
. Willingness and ability to undergo all scheduled examinations and visits during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Corneal Fluorescein Staining

Timeframe: month 2

Trial details

NCT IDNCT07089511

SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

View on ClinicalTrials.gov More Dry Eye trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years.
. Male or female.
. Diagnosis of Dry Eye Disease (DED) with severe keratitis and ocular discomfort related to DED, defined as follows:
. Ability to understand and comply with the protocol requirements (as judged by the investigator).
. Provision of written informed consent and privacy authorization prior to initiation of any study procedures.
. At least 3 months of conventional treatment use (cyclosporine 1 mg/ml and/or hyaluronic acid) for DED prior to the Baseline Visit.
. Willingness and ability to undergo all scheduled examinations and visits during the study.

Cord Blood Platelet Poor Plasma Eye Drops

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Cord Blood Platelet Poor Plasma Eye Drops

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria