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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 : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Bionode, LLC

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.

Condition or disease Intervention/treatment Phase
Unmedicated IOP Before and After Treatment Device: Bionode IOP Lowering System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Study Of The Bionode System In Subjects With Elevated Intraocular Pressure (IOP)
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Test Group 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.

Placebo Comparator: Control Group Device: Bionode IOP Lowering System
Control: No stimulation




Primary Outcome Measures :
  1. 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.

  2. Number of patients with treatment related adverse events [ Time Frame: 1 month post treatment ]
    Incidence of adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093089


Contacts
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Contact: Gabriel Albors, MS 765-496-1827 goa@bionode.net
Contact: Murray Firestone, PhD 317-292-7686 mif@bionode.net

Locations
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Canada, Ontario
Prism Eye Institue Recruiting
Oakville, Ontario, Canada, L6H 0J8
Contact: Ayda Shahidi, PhD    416-899-1421    ayda.shahidi@prismeye.ca   
Sponsors and Collaborators
Bionode, LLC
Investigators
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Study Director: Ayda Shahidi, PhD Prism Eye Institute

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Responsible Party: Bionode, LLC
ClinicalTrials.gov Identifier: NCT04093089    
Other Study ID Numbers: Pro00029387
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No