<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286166</url>
  </required_header>
  <id_info>
    <org_study_id>TOYOS-GENIUSPRP-17-01</org_study_id>
    <nct_id>NCT03286166</nct_id>
  </id_info>
  <brief_title>Single Center, Prospective, Randomized, Controlled, Non-significant Risk</brief_title>
  <official_title>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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Toyos Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Toyos Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial to evaluate the efficiency of serum tears made with Genius PRP&#xD;
      for improving signs and symptoms in Dry Eye Disease (DED).&#xD;
&#xD;
      Single center, Prospective, Randomized, Controlled, Non-significant risk&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Genius PRP is a class II medical device with an 510(k)FDA clearance for platelet and plasma&#xD;
      separation for bone graft handling.&#xD;
&#xD;
      Subjects will sign the IC form within one week of being having been provided the form, at&#xD;
      which time they will undergo the following assessments:&#xD;
&#xD;
        -  Routine ophthalmology tests (biomicroscopy, BCVA and IOP) including corneal fluorescein&#xD;
           staining and lissamine green conjunctival staining&#xD;
&#xD;
        -  Measurement of tear break up time (TBUT) in both eyes. These values will be used as&#xD;
           baseline.&#xD;
&#xD;
        -  Self-administration of the Eye Dryness Scale; 0-100 visual analogue scale. This score&#xD;
           will be used as baseline.&#xD;
&#xD;
        -  Self-administration of Visual Analog Pain Scale&#xD;
&#xD;
        -  Eligible subjects will be randomized with right eye to receive PRP and left eye to&#xD;
           receive vehicle eye drops in the same dosage.&#xD;
&#xD;
      Outcome measures will be assessed in both eyes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>3 months</time_frame>
    <description>Change in EDS questionnaire from baseline&#xD;
Change in TBUT from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The improvement of signs and visual analog pain scale in the study group is larger than the improvement of signs in the control group</measure>
    <time_frame>3 months</time_frame>
    <description>Change in corneal and/or conjunctival SPK&#xD;
Visual analog pain scale</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Study arm</arm_group_label>
    <description>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.&#xD;
• Subjects will utilize autologous tears twice daily in the study eye.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <description>Subjects in the control arm will receive study vehicle to be used twice daily in the left eye.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 20 male or female subjects, aged 22-85, with signs and symptoms of DED and ocular&#xD;
        pain related to DED in the opinion of the investigator&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Able to read, understand and sign an Informed Consent (IC) form 2) 22-85 years of&#xD;
             age 3) Able and willing to comply with the treatment/follow-up schedule and&#xD;
             requirements 4) Tear break up time of less than 10 seconds in both eyes 5) SPK in the&#xD;
             conjunctiva and/or cornea of each eye 6) Eye dryness scale of 40 or greater at&#xD;
             baseline for each eye 7) Self- reported ocular pain from dry eye disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Unwilling to discontinue use of contact lenses for the duration of the study 2) Ocular&#xD;
        surgery or eyelid surgery, within 3 months prior to screening 3) Neuro-paralysis in the&#xD;
        planned treatment area, within 6 months prior to screening 4) Other uncontrolled eye&#xD;
        disorders affecting the ocular surface, for example active allergies 5) Punctal plugs&#xD;
        placed within past 90 days 6) Pre-cancerous lesions, skin cancer or pigmented lesions in&#xD;
        the planned treatment area 7) Uncontrolled infections or uncontrolled immunosuppressive&#xD;
        diseases 8) Subjects with current ocular infections. 9) New prescription eye drops for dry&#xD;
        eye or glaucoma or omega 3 supplements prescribed within 90 days prior to screening,&#xD;
        excluding artificial tears 10) New topical treatments within the area to be treated, or&#xD;
        oral therapies, within 3 months prior to screening- except over-the-counter&#xD;
        acetaminophen-based analgesics for pain management 11) Change in dosage of any systemic&#xD;
        medication, within 3 months prior to screening 12) Anticipated relocation or extensive&#xD;
        travel outside of the local study area preventing compliance with follow-up over the study&#xD;
        period 13) Legally blind in one or both eyes 14) First IPL treatment, within 3 months prior&#xD;
        to screening 15) Any condition revealed during the eligibility screening process whereby&#xD;
        the investigator deems the subject inappropriate for this study&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Toyos Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>December 15, 2017</last_update_submitted>
  <last_update_submitted_qc>December 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03286166/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286166
org study id: TOYOS-GENIUSPRP-17-01
nct id: NCT03286166
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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:

        -  Routine ophthalmology tests (biomicroscopy, BCVA and IOP) including corneal fluorescein
           staining and lissamine green conjunctival staining

        -  Measurement of tear break up time (TBUT) in both eyes. These values will be used as
           baseline.

        -  Self-administration of the Eye Dryness Scale; 0-100 visual analogue scale. This score
           will be used as baseline.

        -  Self-administration of Visual Analog Pain Scale

        -  Eligible subjects will be randomized with right eye to receive PRP and left eye to
           receive vehicle eye drops in the same dosage.

      Outcome measures will be assessed in both eyes.
observational model: Case-Only
time perspective: Retrospective
measure: 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
time frame: 3 months
description: Change in EDS questionnaire from baseline
Change in TBUT from baseline.
measure: The improvement of signs and visual analog pain scale in the study group is larger than the improvement of signs in the control group
time frame: 3 months
description: Change in corneal and/or conjunctival SPK
Visual analog pain scale
arm group label: Study arm
description: 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.
arm group label: Control Arm
description: Subjects in the control arm will receive study vehicle to be used twice daily in the left eye.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
sharing ipd: No
provided document: 