Ignite Creation Date:
2024-05-06 @ 1:40 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04093089
Status:
UNKNOWN
Last Update Posted:
2020-01-22
First Post:
2019-08-27
Brief Title:
Clinical Study Of The Bionode System In Subjects With Elevated IOP
Sponsor:
Bionode LLC
Organization:
Bionode LLC
Study Overview
Official Title:
Clinical Study Of The Bionode System In Subjects With Elevated Intraocular Pressure IOP
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the safety and effectiveness of the Bionode IOP lowering system in eyes with elevated IOP The contact lens being studied is similar to an ordinary contact lens that is worn to correct nearsightedness But the study contact lens has been designed with a thin gold coil around the outside edge of the lens This design helps deliver a low amount of energy to the eye which is expected to help lower the pressure inside of the eye The study contact lens is activated by a pair of glasses Bionode spectacles that you wear to apply the treatment to your eye The study contact lens is only activated when the study glasses are activated
Detailed Description:
Subjects will be randomized in 11 ratio into two groups designated Group A and Group B During the study randomized subjects will be fitted with a pair of study contact lenses only one of which is embedded with a gold coil to receive electrical stimulation from the study spectacles in the study eye Subjects will also wear optical spectacles study spectacles that deliver the electrical stimulus the study contact lenses
Group A will receive electrical stimulation test group and Group B will not receive electrical stimulation control group Baseline IOP will be recorded prior to the 2-hours stimulation and will be repeated post-therapy at increments of 5 minutes 30 minutes 60 minutes and 2 hours from the conclusion of stimulation The total duration of participation for each subject is up to approximately 5 weeks The total expected duration of the clinical trial is approximately 4 months
Group A will receive electrical stimulation test group and Group B will not receive electrical stimulation control group Baseline IOP will be recorded prior to the 2-hours stimulation and will be repeated post-therapy at increments of 5 minutes 30 minutes 60 minutes and 2 hours from the conclusion of stimulation The total duration of participation for each subject is up to approximately 5 weeks The total expected duration of the clinical trial is approximately 4 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None