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Single Center, Prospective, Randomized, Controlled, Non-significant Risk

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ClinicalTrials.gov Identifier: NCT03286166
Recruitment Status : Not yet recruiting
First Posted : September 18, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Toyos Clinic

Brief Summary:

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


Condition or disease
Dry Eye

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

Group/Cohort
Study arm

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.

Control Arm
Subjects in the control arm will receive study vehicle to be used twice daily in the left eye.



Primary Outcome Measures :
  1. 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 ]
    • Change in EDS questionnaire from baseline
    • Change in TBUT from baseline.


Secondary Outcome Measures :
  1. 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 ]
    • Change in corneal and/or conjunctival SPK
    • Visual analog pain scale



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • 1) Able to read, understand and sign an Informed Consent (IC) form 2) 22-85 years of age 3) Able and willing to comply with the treatment/follow-up schedule and requirements 4) Tear break up time of less than 10 seconds in both eyes 5) SPK in the conjunctiva and/or cornea of each eye 6) Eye dryness scale of 40 or greater at baseline for each eye 7) Self- reported ocular pain from dry eye disease

Exclusion Criteria:

1) Unwilling to discontinue use of contact lenses for the duration of the study 2) Ocular surgery or eyelid surgery, within 3 months prior to screening 3) Neuro-paralysis in the planned treatment area, within 6 months prior to screening 4) Other uncontrolled eye disorders affecting the ocular surface, for example active allergies 5) Punctal plugs placed within past 90 days 6) Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area 7) Uncontrolled infections or uncontrolled immunosuppressive diseases 8) Subjects with current ocular infections. 9) New prescription eye drops for dry eye or glaucoma or omega 3 supplements prescribed within 90 days prior to screening, excluding artificial tears 10) New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management 11) Change in dosage of any systemic medication, within 3 months prior to screening 12) Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period 13) Legally blind in one or both eyes 14) First IPL treatment, within 3 months prior to screening 15) Any condition revealed during the eligibility screening process whereby the investigator deems the subject inappropriate for this study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286166


Locations
United States, Tennessee
Toyos Clinic
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Toyos Clinic
  Study Documents (Full-Text)

Documents provided by Toyos Clinic:
Study Protocol  [PDF] September 7, 2017


Responsible Party: Toyos Clinic
ClinicalTrials.gov Identifier: NCT03286166     History of Changes
Other Study ID Numbers: TOYOS-GENIUSPRP-17-01
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases