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Clinical Study Of The Bionode System In Subjects With Elevated IOP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093089
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bionode, LLC

Tracking Information
First Submitted Date  ICMJE August 27, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE July 17, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
  • Intraocular pressure (mmHg) [ Time Frame: 0 min (baseline), 5 min, 30 min, 60 min, and 120 min post treatment ]
    The primary effectiveness outcome is defined unmedicated IOP after treatment, at 0 min (baseline), 5 min, 30 min, 60 min, and 120 min. An area under the curve will be calculated from the IOP measures at the 5 time points.
  • Number of patients with treatment related adverse events [ Time Frame: 1 month post treatment ]
    Incidence of adverse events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study Of The Bionode System In Subjects With Elevated IOP
Official Title  ICMJE Clinical Study Of The Bionode System In Subjects With Elevated Intraocular Pressure (IOP)
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 1:1 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Unmedicated IOP Before and After Treatment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Test Group
    Intervention: Device: Bionode IOP Lowering System
  • Placebo Comparator: Control Group
    Intervention: Device: Bionode IOP Lowering System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject ability and willingness to read, comprehend and signed the informed consent form.
  2. Subject willingness to comply with study instructions, agreement to make all office appointments, and complete the entire course of the study.
  3. Clinical diagnosis of primary open-angle glaucoma (POAG) or ocular hypertension (OHT) with IOP > 22 mmHg.
  4. Subjects > 22 years of age at the time of the screening examination.
  5. Central corneal thickness of > 450 µm and < 650 µm in study eye
  6. Best-corrected visual acuity (BCVA) or pinhole visual acuity (Snellen) of 20/100 or better in study eye.
  7. Subjects with an angle of grade 2 or above via the Shaffer grading system

Exclusion Criteria:

  1. Angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
  2. Corneal endothelial dysfunction or abnormalities (e.g., Fuchs' Corneal Dystrophy) in either eye
  3. Known sensitivity to any products (e.g., contact lens) required for the study procedures
  4. A vertical cup to disc ratio of > 0.8, or notched optic nerve head rim in either eye
  5. Visual defect within 10 degrees of fixation or mean deviation of worse than -10 dB
  6. History of complications, trauma or disease in the nasolacrimal area.
  7. Structural lid abnormalities (i.e., ectropion, entropion) in study eye
  8. Active lid disease in either eye (i.e., moderate or severe blepharitis, Meibomian gland dysfunction) that requires medical treatment
  9. History of chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye
  10. Any ophthalmic surgical procedures (i.e., glaucoma laser, minimally invasive glaucoma surgery, refractive, etc.) in study eye within the last six months or will require ophthalmic surgery before completing study
  11. History of penetrating keratoplasty in study eye
  12. Use of a contact lens in either eye at any time during the study period
  13. Uncontrolled diabetic retinopathy, branch retinal vein occlusion or central retinal vein occlusion in either eye
  14. Any systemic medication [i.e., beta-blocker, carbonic anhydrase inhibitors, corticosteroids (including dermal), etc.], that may have an effect on the subject's IOP, or who will require its use during the study period (Note: an inhaled steroid, systemic beta-blocker or β-adrenoceptor antagonist may be permitted, providing the subject has maintained a stable dosage regimen for at least the last three months)
  15. Women who are pregnant or lactating.
  16. Severe dry eyes.
  17. LASIK surgery.
  18. Subject currently participating or has participated within the last 30 days prior to the start of this study in a drug, device or other investigational research study
  19. Subject who cannot be successfully fitted with Bionode spectacles and wear contact lenses (if applicable) at the Baseline Visit (day 0)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabriel Albors, MS 765-496-1827 goa@bionode.net
Contact: Murray Firestone, PhD 317-292-7686 mif@bionode.net
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04093089
Other Study ID Numbers  ICMJE Pro00029387
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bionode, LLC
Study Sponsor  ICMJE Bionode, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ayda Shahidi, PhD Prism Eye Institute
PRS Account Bionode, LLC
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP