Dry Eye Disease (DED)Phase 1/2DEDNCT07551843
Comparative Effects of Autologous Serum, Umbilical Cord Blood-Derived Drops, and Platelet Lysate on Ocular Surface Parameters
A Phase 1/2 study testing Autologous serum eyedrops, Autologous Platelet Lysate and Umbilical Cord Blood Platelet Lysate in people with Dry Eye Disease (DED), run by G.Gennimatas General Hospital at 1 site in Greece.
Trial summary
In this study, patients are randomly assigned to the study groups (autologous peripheral blood, umbilical cord blood, autologous serum). Each patient, who wishes to undergo any treatment, has the right to be informed about their disease and the recommended treatment by the treating physician so that they can decide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Autologous serum eyedrops, Autologous Platelet Lysate and Umbilical Cord Blood Platelet Lysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 17 Oct 2023to 31 Dec 2024
- Phase
- Phase 1/2
- 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>18years
- Dry Eye Disease in chronic blepharitis
- Dry Eye Disease in Sjogren syndrome
- Toxic keratopathy/Dry Eye Disease after use of anti-glaucoma eye drops
Who cannot join
- Age<18years
- Active infectious disease
Trial locations and contacts
1 site in 1 country.
Greece1 site
Gna Georgios Gennimatas 1St Ophthalmology Clinic
Athens, Attica, 11527
About this study
Official title: Comparative Study of the Efficacy of Eye Drops Derived From Autologous Peripheral Blood and Umbilical Cord Blood in Patients With Ocular Surface Disease
In this study, patients are randomly assigned to the study groups (autologous peripheral blood, umbilical cord blood, autologous serum). Each patient, who wishes to undergo any treatment, has the right to be informed about their disease and the recommended treatment by the treating physician so that they can decide whether to proceed with it or not.
During the study, you will need to complete an eye symptom assessment questionnaire (Ocular Surface Disease Index - OSDI).
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Autologous serum eyedrops, Autologous Platelet Lysate, Umbilical Cord Blood Platelet Lysate
- Keywords
- Dry Eye Disease-DED, Autologous Serum, Autologous Platelet Lysate, Cord Blood Platelet Lysate
- 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.
Autologous serum eyedropsBiological
For Autologous Serum preparation, 50 ml of peripheral blood were collected and centrifuged at 4000 g at +8°C for 15 minutes. A total of 3.5 ml of saline from preservative free eye drops was replaced with 3.5 ml of autologous serum. Infectious disease screening matched that of the PL group. Final products were stored for one week at +4°C and up to four weeks at -20°C.
Autologous Platelet LysateBiological
Fifty milliliters of peripheral blood were collected in anticoagulated tubes and centrifuged at 900 g for 10 minutes to isolate platelet rich plasma (PRP). PRP was diluted to 30% (v/v) with sterile saline, frozen at -80°C for at least 60 minutes (thermal shock), and rapidly thawed at 4°C to induce platelet lysis. The resulting PL was aliquoted into sterile containers and stored at -20°C for approximately 45 days. On the day of use, vials were thawed at 4°C. After production, the eye drops were placed in sterile 5 ml and 10 ml containers with a dropper tip
Umbilical Cord Blood Platelet LysateBiological
CB derived PL was produced based on the PL production process according to the already published protocol of the Hellenic Cord Blood Bank (HCBB) using cord blood units from full term pregnancies (38-40 weeks) that were unsuitable for transplantation according to the criteria of the World Accreditation Organization "FACT-NetCord" but donated for research with informed consent which was obtained prior to delivery and was in accordance with the National Bioethics Committee according to Helsinki declaration. PRP was isolated via double centrifugation, frozen at -80°C for at least 24 hours, and rapidly thawed at 37°C to release platelet derived growth factors. The lysate was filtered through a 0.22 μm non pyrogenic filter and aliquoted into 5-10 ml vials. Up to 10 ml of PL were obtained per cord blood unit. CB eye drops were stored at -20°C for up to 30 days without measurable loss of growth factor content.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Platelet Lysate | Active comparator | Fifty milliliters of peripheral blood were collected in anticoagulated tubes and centrifuged at 900 g for 10 minutes to isolate platelet rich plasma (PRP). PRP was diluted to 30% (v/v) with sterile saline, frozen at -80°C for at least 60 minutes (thermal shock), and rapidly thawed at 4°C to induce platelet lysis. The resulting PL was aliquoted into sterile containers of 5 ml and 10 ml with a dropper tip, thus ensuring ease of administration to the patients' eyes. and stored at -20°C for approximately 45 days. On the day of use, vials were thawed at 4°C. Receives: Biological: Autologous Platelet Lysate |
| Umbilical Cord Blood Platelet Lysate | Active comparator | CB derived PL was produced based on the PL production process according to the already published protocol of the Hellenic Cord Blood Bank (HCBB) using cord blood units from full term pregnancies (38-40 weeks) that were unsuitable for transplantation according to the criteria of the World Accreditation Organization "FACT-NetCord" but donated for research with informed consent which was obtained prior to delivery and was in accordance with the National Bioethics Committee according to Helsinki declaration. PRP was isolated via double centrifugation, frozen at -80°C for at least 24 hours, and rapidly thawed at 37°C to release platelet derived growth factors. The lysate was filtered through a 0.22 μm non pyrogenic filter and aliquoted into 5-10 ml vials. Up to 10 ml of PL were obtained per cord blood unit. CB eye drops were stored at -20°C for up to 30 days without measurable loss of growth factor content. Receives: Biological: Umbilical Cord Blood Platelet Lysate |
| Autologous Serum | Active comparator | For Autologous Serum preparation, 50 ml of peripheral blood were collected and centrifuged at 4000 g at +8°C for 15 minutes. A total of 3.5 ml of saline from preservative free eye drops was replaced with 3.5 ml of autologous serum. Infectious disease screening matched that of the PL group. Final products were stored for one week at +4°C and up to four weeks at -20°C. Receives: Biological: Autologous serum eyedrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Dry Eye Disease parameters (Total Break-Up time)
For the assessment of the stability of the tear film, its breakup time was examined, that is, the time between the last blink and the appearance of the first dry spot after instillation of 2% fluorescein into the eye. A time of less than 5 seconds is considered indicative of ocular surface disease.
Measured: From enrollment to the end of treatment at 4 weeks
Improvement of Dry Eye Disease parameters (Schirmer test)
For the assessment of tear production, the Schirmer test was used (amount of wetting of a special filter paper), the examination was performed without the use of local anesthesia. If the length of wetting after 5 minutes is less than 10 mm, then it is considered pathological.
Measured: From enrollment to the end of treatment at 4 weeks
Improvement of Dry Eye Disease parameters (Oxford Grading Scale)
The Oxford Scale grades ocular surface staining from 0 to 5, where 0 indicates no staining and 5 indicates severe corneal damage. It measures the severity of corneal staining using dyes like fluorescein.
Measured: From enrollment to the end of treatment at 4 weeks
Improvement of Dry Eye Disease parameters (Ocular Surface Disease Index-OSDI)
The OSDI is a 12-item questionnaire assessing ocular symptoms, visual functioning, and environmental triggers. Each is scored 0-4 and converted to a 0-100 total score. Scores classify as normal, mild, moderate, severe.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start17 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research Foundation, Academy of Athens
- Responsible party
- Principal investigator, Konstantinos Douglas, G.Gennimatas General Hospital
- Investigators
- Konstantinos Droutsas, Associate Professor Ophthalmol, Study chair, 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, GreeceGeorgios Kymionis, Professor in Ophthalmology, Study director, 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, GreeceDimitris Papaconstantinou, Professor in Ophthalmology, Study director, 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551843
- Sponsor's protocol ID
- 27057
- Acronym
- DED
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy of Eye Drops Derived From Autologous Peripheral Blood and Umbilical Cord Blood in Patients With Ocular Surface Disease
- ClinicalTrials.gov ID
- NCT07551843
- Acronym / sponsor ID
- DED / 27057
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry Eye Disease-DED, Autologous Serum, Autologous Platelet Lysate, Cord Blood Platelet Lysate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Collaborators
- Biomedical Research Foundation, Academy of Athens
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Apr 2026 (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.
In this study, patients are randomly assigned to the study groups (autologous peripheral blood, umbilical cord blood, autologous serum). Each patient, who wishes to undergo any treatment, has the right to be informed about their disease and the recommended treatment by the treating physician so that they can decide whether to proceed with it or not.
During the study, you will need to complete an eye symptom assessment questionnaire (Ocular Surface Disease Index - OSDI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autologous Platelet Lysate | Active comparator | Biological: Autologous Platelet LysateFifty milliliters of peripheral blood were collected in anticoagulated tubes and centrifuged at 900 g for 10 minutes to isolate platelet rich plasma (PRP). PRP was diluted to 30% (v/v) with sterile saline, frozen at -80°C for at least 60 minutes (thermal shock), and rapidly thawed at 4°C to induce platelet lysis. The resulting PL was aliquoted into sterile containers of 5 ml and 10 ml with a dropper tip, thus ensuring ease of administration to the patients' eyes. and stored at -20°C for approximately 45 days. On the day of use, vials were thawed at 4°C. |
| Umbilical Cord Blood Platelet Lysate | Active comparator | Biological: Umbilical Cord Blood Platelet LysateCB derived PL was produced based on the PL production process according to the already published protocol of the Hellenic Cord Blood Bank (HCBB) using cord blood units from full term pregnancies (38-40 weeks) that were unsuitable for transplantation according to the criteria of the World Accreditation Organization "FACT-NetCord" but donated for research with informed consent which was obtained prior to delivery and was in accordance with the National Bioethics Committee according to Helsinki declaration. PRP was isolated via double centrifugation, frozen at -80°C for at least 24 hours, and rapidly thawed at 37°C to release platelet derived growth factors. The lysate was filtered through a 0.22 μm non pyrogenic filter and aliquoted into 5-10 ml vials. Up to 10 ml of PL were obtained per cord blood unit. CB eye drops were stored at -20°C for up to 30 days without measurable loss of growth factor content. |
| Autologous Serum | Active comparator | Biological: Autologous serum eyedropsFor Autologous Serum preparation, 50 ml of peripheral blood were collected and centrifuged at 4000 g at +8°C for 15 minutes. A total of 3.5 ml of saline from preservative free eye drops was replaced with 3.5 ml of autologous serum. Infectious disease screening matched that of the PL group. Final products were stored for one week at +4°C and up to four weeks at -20°C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18years
- Dry Eye Disease in chronic blepharitis
- Dry Eye Disease in Sjogren syndrome
- Toxic keratopathy/Dry Eye Disease after use of anti-glaucoma eye drops
Key exclusion criteria (2 listed)
- Age<18years
- Active infectious disease
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 |
|---|---|---|
| Autologous serum eyedropsFor Autologous Serum preparation, 50 ml of peripheral blood were collected and centrifuged at 4000 g at +8°C for 15 minutes. A total of 3.5 ml of saline from preservative free eye drops was replaced with 3.5 ml of autologous serum. Infectious disease screening matched that of the PL group. Final products were stored for one week at +4°C and up to four weeks at -20°C. | Biological | Autologous Serum |
| Autologous Platelet LysateFifty milliliters of peripheral blood were collected in anticoagulated tubes and centrifuged at 900 g for 10 minutes to isolate platelet rich plasma (PRP). PRP was diluted to 30% (v/v) with sterile saline, frozen at -80°C for at least 60 minutes (thermal shock), and rapidly thawed at 4°C to induce platelet lysis. The resulting PL was aliquoted into sterile containers and stored at -20°C for approximately 45 days. On the day of use, vials were thawed at 4°C. After production, the eye drops were placed in sterile 5 ml and 10 ml containers with a dropper tip | Biological | Autologous Platelet Lysate |
| Umbilical Cord Blood Platelet LysateCB derived PL was produced based on the PL production process according to the already published protocol of the Hellenic Cord Blood Bank (HCBB) using cord blood units from full term pregnancies (38-40 weeks) that were unsuitable for transplantation according to the criteria of the World Accreditation Organization "FACT-NetCord" but donated for research with informed consent which was obtained prior to delivery and was in accordance with the National Bioethics Committee according to Helsinki declaration. PRP was isolated via double centrifugation, frozen at -80°C for at least 24 hours, and rapidly thawed at 37°C to release platelet derived growth factors. The lysate was filtered through a 0.22 μm non pyrogenic filter and aliquoted into 5-10 ml vials. Up to 10 ml of PL were obtained per cord blood unit. CB eye drops were stored at -20°C for up to 30 days without measurable loss of growth factor content. | Biological | Umbilical Cord Blood Platelet Lysate |
Primary outcome
Improvement of Dry Eye Disease parameters (Total Break-Up time)
Time frame: From enrollment to the end of treatment at 4 weeks
For the assessment of the stability of the tear film, its breakup time was examined, that is, the time between the last blink and the appearance of the first dry spot after instillation of 2% fluorescein into the eye. A time of less than 5 seconds is considered indicative of ocular surface disease.
Improvement of Dry Eye Disease parameters (Schirmer test)
Time frame: From enrollment to the end of treatment at 4 weeks
For the assessment of tear production, the Schirmer test was used (amount of wetting of a special filter paper), the examination was performed without the use of local anesthesia. If the length of wetting after 5 minutes is less than 10 mm, then it is considered pathological.
Improvement of Dry Eye Disease parameters (Oxford Grading Scale)
Time frame: From enrollment to the end of treatment at 4 weeks
The Oxford Scale grades ocular surface staining from 0 to 5, where 0 indicates no staining and 5 indicates severe corneal damage. It measures the severity of corneal staining using dyes like fluorescein.
Improvement of Dry Eye Disease parameters (Ocular Surface Disease Index-OSDI)
Time frame: From enrollment to the end of treatment at 4 weeks
The OSDI is a 12-item questionnaire assessing ocular symptoms, visual functioning, and environmental triggers. Each is scored 0-4 and converted to a 0-100 total score. Scores classify as normal, mild, moderate, severe.
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 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Konstantinos Droutsas, Associate Professor Ophthalmol study chair
1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece
Georgios Kymionis, Professor in Ophthalmology study director
1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece
Dimitris Papaconstantinou, Professor in Ophthalmology study director
1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous serum eyedrops, Autologous Platelet Lysate and Umbilical Cord Blood Platelet Lysate in people with Dry Eye Disease (DED), run by G.Gennimatas General Hospital at 1 site in Greece.
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 4 inclusion and 2 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 27 Apr 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 Greece. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement of Dry Eye Disease parameters (Total Break-Up time) (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 4 primary outcomes in all. 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 27 Apr 2026.