Comparative Effects of Autologous Serum, Umbilical Cord Blood-Derived Drops, and Platelet Lysate on Ocular Surface Parameters (DED)

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Biological: Autologous Platelet Lysate; Biological: Umbilical Cord Blood Platelet Lysate; Biological: Autologous serum eyedrops

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • Gna Georgios Gennimatas 1St Ophthalmology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age<18years
• Active infectious disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autologous Platelet Lysate; 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.	Biological: Autologous Platelet Lysate; 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
Active Comparator: Umbilical Cord Blood Platelet Lysate; 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.	Biological: Umbilical Cord Blood Platelet Lysate; 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.
Active Comparator: Autologous Serum; 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.	Biological: Autologous serum eyedrops; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: G.Gennimatas General Hospital
• Collaborators: Biomedical Research Foundation of the Academy of Athens
• Investigators: Study Chair: Konstantinos Droutsas, Associate Professor Ophthalmol, 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece; Study Director: Georgios Kymionis, Professor in Ophthalmology, 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece; Study Director: Dimitris Papaconstantinou, Professor in Ophthalmology, 1st Department of Ophthalmology at the G. Gennimatas General Hospital in Athens, Greece

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Autologous Serum; Dry Eye Disease-DED; Autologous Platelet Lysate; Cord Blood Platelet Lysate
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 27057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No