Dry EyeCB3P-EDNCT07089511
Cord Blood Platelet Poor Plasma Eye Drops
A study testing CB3P-ED + 0.1% cyclosporine eye drops and 0.15% hyaluronic acid + 0.1% cyclosporine eye drops in people with Dry Eye, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- CB3P-ED + 0.1% cyclosporine eye drops and 0.15% hyaluronic acid + 0.1% cyclosporine eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Male or female.
- Diagnosis of Dry Eye Disease (DED) with severe keratitis and ocular discomfort related to DED, defined as follows:
- Corneal Fluorescein Staining (CFS) score of 3, 4, or 5 on the modified Oxford scale in at least one eye at the Baseline Visit, combined with at least one of the following criteria:
- Schirmer test without anesthesia with a score <10 mm/5 min in the same eye at the Baseline Visit.
- Ocular Surface Disease Index (OSDI) score of at least 30, or presence of at least two moderate to severe dry eye symptoms with a severity score above 50 (severity assessed on a scale of 0 to 100), including any of the following symptoms: burning/stinging, foreign body sensation, ocular dryness, ocular pain, and blurred/decreased vision at the Baseline Visit.
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- 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.
Who cannot join
- Active herpetic keratitis or history of ocular herpes.
- History of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days prior to the Baseline Visit.
- Any ocular disease other than Dry Eye Disease (DED) requiring topical ocular treatment during the study period.
- Ocular rosacea and/or severe blepharitis.
- Progressive pterygium.
- Concurrent ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.
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- Planned insertion of temporary punctal plugs during the study period.
- Best corrected visual acuity (BCVA) score ≤ 0.1 (decimal notation) in either eye.
- Unstable systemic disease within 30 days prior to the Baseline Visit (e.g., diabetes with out-of-range blood glucose, thyroid dysfunction, uncontrolled autoimmune disease, ongoing systemic infections) or conditions judged by the investigator as incompatible with study participation.
- Presence or history of severe systemic allergy.
- Known hypersensitivity to any of the products used in the study (cyclosporine, fluorescein, lissamine green, hyaluronic acid) or their components.
- History of ocular malignancy.
- History of malignancy (other than ocular) within the last 5 years.
- Any changes within 30 days prior to the Baseline Visit, or anticipated changes during the study, in the dosage of systemic medications that may affect dry eye condition [e.g., estrogen-progesterone or other estrogen derivatives, pilocarpine, isotretinoin, tetracycline, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blockers, phenothiazines, omega-3 fatty acids, systemic corticosteroids]. These treatments are permitted during the study provided their dosage remains stable throughout.
- Any changes in systemic immunosuppressive therapy within 30 days prior to the Baseline Visit or anticipated changes during the study.
- History of substance abuse or alcohol dependence.
- Presence or history of any systemic or ocular disorder, condition, or disease that could interfere with the conduct of study procedures or interpretation of study results.
- Pregnancy or breastfeeding at the time of the Baseline Visit.
- Women of childbearing potential unwilling to use a highly effective method of contraception (see section 5.2.2) from the Baseline Visit throughout the treatment period and up to 2 weeks after study completion. Postmenopausal women (defined as ≥ 2 years without menstruation) are exempt from contraception requirements.
- Participation in a clinical trial involving an investigational product within 30 days prior to the Baseline Visit.
- Concurrent participation in another clinical trial during the present study.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- CB3P-ED + 0.1% cyclosporine eye drops, 0.15% hyaluronic acid + 0.1% cyclosporine eye drops
- Keywords
- Cord Blood Platelet Poor Plasma, dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB3P-ED + 0.1% cyclosporine eye dropsOther
Combination of CB3P-ED + 0.1% cyclosporine eye drops
0.15% hyaluronic acid + 0.1% cyclosporine eye dropsOther
Combination of 0.15% hyaluronic acid + 0.1% cyclosporine eye drops
| Study group | Role | What they receive |
|---|---|---|
| CB3P-ED | Experimental | Not described Receives: Other: CB3P-ED + 0.1% cyclosporine eye drops |
| 0.15% hyaluronic acid | Active comparator | Not described Receives: Other: 0.15% hyaluronic acid + 0.1% cyclosporine eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Fluorescein Staining
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.The score was calculated using the modified oxford scale, a standardized, seven point visual grading system (0 to 5), where higher scores indicate greater corneal epithelial damage (worse outcome). The efficacy of the treatment is reflected by a greater reduction in the score from baseline.
Measured: month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start11 Mar 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Viola, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089511
- Sponsor's protocol ID
- CB3P-ED
- Other IDs
- PNRR-MCNT2-2023-12377596
- Acronym
- CB3P-ED
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cord Blood Platelet Poor Plasma Eye Drops
- ClinicalTrials.gov ID
- NCT07089511
- Acronym / sponsor ID
- CB3P-ED / CB3P-ED
- Conditions
- Dry Eye
- Keywords
- Cord Blood Platelet Poor Plasma, dry eye disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CB3P-ED | Experimental | Other: CB3P-ED + 0.1% cyclosporine eye drops |
| 0.15% hyaluronic acid | Active comparator | Other: 0.15% hyaluronic acid + 0.1% cyclosporine eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years.
- Male or female.
- Diagnosis of Dry Eye Disease (DED) with severe keratitis and ocular discomfort related to DED, defined as follows:
- Corneal Fluorescein Staining (CFS) score of 3, 4, or 5 on the modified Oxford scale in at least one eye at the Baseline Visit, combined with at least one of the following criteria:
- Ability to understand and comply with the protocol requirements (as judged by the investigator).
Key exclusion criteria (21 listed)
- Active herpetic keratitis or history of ocular herpes.
- History of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days prior to the Baseline Visit.
- Any ocular disease other than Dry Eye Disease (DED) requiring topical ocular treatment during the study period.
- Ocular rosacea and/or severe blepharitis.
- Progressive pterygium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CB3P-ED + 0.1% cyclosporine eye dropsCombination of CB3P-ED + 0.1% cyclosporine eye drops | Other | CB3P-ED |
| 0.15% hyaluronic acid + 0.1% cyclosporine eye dropsCombination of 0.15% hyaluronic acid + 0.1% cyclosporine eye drops | Other | 0.15% hyaluronic acid |
Primary outcome
Corneal Fluorescein Staining
Time frame: 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.The score was calculated using the modified oxford scale, a standardized, seven point visual grading system (0 to 5), where higher scores indicate greater corneal epithelial damage (worse outcome). The efficacy of the treatment is reflected by a greater reduction in the score from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Viola, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CB3P-ED + 0.1% cyclosporine eye drops and 0.15% hyaluronic acid + 0.1% cyclosporine eye drops in people with Dry Eye, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Fluorescein Staining (time frame: month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.