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Clinical Study Of The Bionode System In Subjects With Elevated IOP

NCT04093089 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-22

No results posted yet for this study

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.

Conditions

  • Unmedicated IOP Before and After Treatment

Interventions

DEVICE

Bionode IOP Lowering System

Patients wearing Bionode spectacles and customized contact lens and will receive stimulation at 50 Hz, 100 µs, up to 150 µA for 2 hours.

DEVICE

Bionode IOP Lowering System

Control: No stimulation

Sponsors & Collaborators

  • Bionode, LLC

    lead INDUSTRY

Principal Investigators

  • Ayda Shahidi, PhD · Prism Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04093089 on ClinicalTrials.gov