Dry Eye Clinical Trial
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)
Verified date | December 2023 |
Source | Toyos Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 85 Years |
Eligibility | 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 - |
Country | Name | City | State |
---|---|---|---|
United States | Toyos Clinic | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Toyos Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
3 months | |
Secondary | 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 |
3 months |
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