An observational study in Dry Eye, sponsored by Toyos Clinic. Withdrawn at 1 site in United States. Open to participants aged 22 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Toyos Clinic · Observational
A randomized controlled trial to evaluate the efficiency of serum tears made with Genius PRP for improving signs and symptoms in Dry Eye Disease (DED).
Single center, Prospective, Randomized, Controlled, Non-significant risk
Genius PRP is a class II medical device with an 510(k)FDA clearance for platelet and plasma separation for bone graft handling.
Subjects will sign the IC form within one week of being having been provided the form, at which time they will undergo the following assessments:
Outcome measures will be assessed in both eyes.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
Browse Dry Eye Syndromes studies →Toyos Clinic is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Up to 20 male or female subjects, aged 22-85, with signs and symptoms of DED and ocular pain related to DED in the opinion of the investigator
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 subjects will undergo one session of PRP in which 60 cc of blood is drawn and centrifuged into 3 months of autologous serum tears. • Subjects will utilize autologous tears twice daily in the study eye.
Subjects in the control arm will receive study vehicle to be used twice daily in the left eye.
The difference in the change of EDS score from baseline and the tear breakup time from baseline to follow-up, between study eyes in the study arm and study eyes in the control arm
* Change in EDS questionnaire from baseline * Change in TBUT from baseline.
Time frame: 3 months
The improvement of signs and visual analog pain scale in the study group is larger than the improvement of signs in the control group
* Change in corneal and/or conjunctival SPK * Visual analog pain scale
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2021.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Toyos Clinic