CClinicalTrials.gg
WithdrawnNCT03286166Updated Dec 12, 2023

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

An observational study in Dry Eye, sponsored by Toyos Clinic. Withdrawn at 1 site in United States. Open to participants aged 22 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Toyos Clinic · Observational

Why this study was withdrawn
due to funding issues
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
0
Ages
22 Years to 85 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
22 Years to 85 Years
Sexes eligible
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

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

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

-

04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: 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

    * Change in corneal and/or conjunctival SPK * Visual analog pain scale

    Time frame: 3 months

06

Study locations

1 site
  • Toyos Clinic
    Nashville, Tennessee 37203, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03286166
Lead sponsor
Toyos Clinic
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Dec 1, 2021 (estimated)
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022
Last update
Dec 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion