Status:
WITHDRAWN
Single Center, Prospective, Randomized, Controlled, Non-significant Risk
Lead Sponsor:
Toyos Clinic
Conditions:
Dry Eye
Eligibility:
All Genders
22-85 years
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, Control...
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
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Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03286166
Start Date
December 1 2021
End Date
October 31 2022
Last Update
December 12 2023
Active Locations (1)
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1
Toyos Clinic
Nashville, Tennessee, United States, 37203