Comparative Effects of Autologous Serum, Umbilical Cord Blood-Derived Drops, and Platelet Lysate … (NCT07551843) | Clinical Trial Compass
CompletedPhase 1/2
Comparative Effects of Autologous Serum, Umbilical Cord Blood-Derived Drops, and Platelet Lysate on Ocular Surface Parameters
Greece80 participantsStarted 2023-10-17
Plain-language 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 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).
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\>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
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.
1This trial compared three different biological eye drops — autologous serum, umbilical cord blood-derived drops, and platelet lysate — for dry eye disease. Based on the results, did any one of these treatments show a meaningful difference in tests like tear break-up time or the OSDI symptom score, and would my doctor consider any of them for my situation?
2Since this was a Phase 1/2 trial, the primary focus was still on establishing safety alongside early effectiveness — does my doctor think the safety profile looks acceptable enough to consider one of these approaches, or should I wait for larger studies before exploring them?
3The trial used the Oxford Grading Scale to measure damage to the eye surface — can my doctor tell me how severe my own surface damage is using that scale, and whether it matches the kind of patients who were enrolled in this study?
4The Schirmer test was one of the outcomes measured here — my doctor already has my tear production data, so do my results suggest I might benefit from a biologic drop like the ones tested, compared to standard dry eye treatments I may not have tried yet?
5Now that this trial is completed, are the findings published or available anywhere, and can my doctor review the actual results to help us decide whether pursuing one of these biological drop options makes sense for me specifically?
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
1
Improvement of Dry Eye Disease parameters (Total Break-Up time)
Timeframe: From enrollment to the end of treatment at 4 weeks
2
Improvement of Dry Eye Disease parameters (Schirmer test)
Timeframe: From enrollment to the end of treatment at 4 weeks
3
Improvement of Dry Eye Disease parameters (Oxford Grading Scale)
Timeframe: From enrollment to the end of treatment at 4 weeks
4
Improvement of Dry Eye Disease parameters (Ocular Surface Disease Index-OSDI)
Timeframe: From enrollment to the end of treatment at 4 weeks