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

NCT03286166 | Withdrawn

• 1 other identifier: TOYOS-GENIUSPRP-17-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (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

  * Change in EDS questionnaire from baseline * Change in TBUT from baseline.

  3 months

Secondary Outcomes (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

  3 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Toyos Clinic: lead

Study Sites (1)

Toyos Clinic

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 18, 2017
• Study Start: December 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)