Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-03-06 @ 3:01 AM
Study NCT ID:
NCT03286166
Status:
WITHDRAWN
Last Update Posted:
2023-12-12
First Post:
2017-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Center, Prospective, Randomized, Controlled, Non-significant Risk
Sponsor:
Toyos Clinic
Organization:
Study Overview
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)
Status:
WITHDRAWN
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to funding issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: