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

NCT ID: NCT03286166

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-10-31

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

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.

Conditions

Dry Eye

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Control Arm

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

No interventions assigned to this group

Eligibility 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

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• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Toyos Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toyos Clinic

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

TOYOS-GENIUSPRP-17-01

Identifier Type: -

Identifier Source: org_study_id