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NCT Number: NCT07551843

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

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).

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gna Georgios Gennimatas 1St Ophthalmology Clinic

Athens, Attica, 11527, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous serum eyedrops

Biological

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 Lysate

Biological

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 Lysate

Biological

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

G.Gennimatas General Hospital

Other

Collaborators

  • Biomedical Research Foundation, Academy of Athens

Registry information

Official study title

Comparative Study of the Efficacy of Eye Drops Derived From Autologous Peripheral Blood and Umbilical Cord Blood in Patients With Ocular Surface Disease

Acronym: DED

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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