Unmedicated IOP Before and After TreatmentNCT04093089
Clinical Study Of The Bionode System In Subjects With Elevated IOP
A study testing Bionode IOP Lowering System in people with Unmedicated IOP Before and After Treatment, run by Bionode, LLC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Unmedicated IOP Before and After Treatment
- What is being tested?
- Bionode IOP Lowering System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject ability and willingness to read, comprehend and signed the informed consent form.
- Subject willingness to comply with study instructions, agreement to make all office appointments, and complete the entire course of the study.
- Clinical diagnosis of primary open-angle glaucoma (POAG) or ocular hypertension (OHT) with IOP > 22 mmHg.
- Subjects > 22 years of age at the time of the screening examination.
- Central corneal thickness of > 450 µm and < 650 µm in study eye
- Best-corrected visual acuity (BCVA) or pinhole visual acuity (Snellen) of 20/100 or better in study eye.
- Subjects with an angle of grade 2 or above via the Shaffer grading system
Who cannot join
- Angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
- Corneal endothelial dysfunction or abnormalities (e.g., Fuchs' Corneal Dystrophy) in either eye
- Known sensitivity to any products (e.g., contact lens) required for the study procedures
- A vertical cup to disc ratio of > 0.8, or notched optic nerve head rim in either eye
- Visual defect within 10 degrees of fixation or mean deviation of worse than -10 dB
- History of complications, trauma or disease in the nasolacrimal area.
Show all 19Show fewer
- Structural lid abnormalities (i.e., ectropion, entropion) in study eye
- Active lid disease in either eye (i.e., moderate or severe blepharitis, Meibomian gland dysfunction) that requires medical treatment
- History of chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye
- 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
- History of penetrating keratoplasty in study eye
- Use of a contact lens in either eye at any time during the study period
- Uncontrolled diabetic retinopathy, branch retinal vein occlusion or central retinal vein occlusion in either eye
- 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)
- Women who are pregnant or lactating.
- Severe dry eyes.
- LASIK surgery.
- 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
- Subject who cannot be successfully fitted with Bionode spectacles and wear contact lenses (if applicable) at the Baseline Visit (day 0)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Prism Eye Institue
Oakville, Ontario, L6H 0J8
Ayda Shahidi, PhD, 416-899-1421, ayda.shahidi@prismeye.ca
About this study
Official title: Clinical Study Of The Bionode System In Subjects With Elevated Intraocular Pressure (IOP)
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.
Read the 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.
- Being tested
- Bionode IOP Lowering System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionode IOP Lowering SystemDevice
Patients wearing Bionode spectacles and customized contact lens and will receive stimulation at 50 Hz, 100 µs, up to 150 µA for 2 hours.
Bionode IOP Lowering SystemDevice
Control: No stimulation
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Device: Bionode IOP Lowering System |
| Control Group | Placebo comparator | Not described Receives: Device: Bionode IOP Lowering System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (mmHg)
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.
Measured: 0 min (baseline), 5 min, 30 min, 60 min, and 120 min post treatment
Number of patients with treatment related adverse events
Incidence of adverse events.
Measured: 1 month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start17 Jul 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unmedicated IOP Before and After TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionode, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ayda Shahidi, PhD, Study director, Prism Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093089
- Sponsor's protocol ID
- Pro00029387
- Status last verified
- Jan 2020
- First submitted
- 27 Aug 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Of The Bionode System In Subjects With Elevated Intraocular Pressure (IOP)
- ClinicalTrials.gov ID
- NCT04093089
- Acronym / sponsor ID
- Pro00029387
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bionode, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Bionode IOP Lowering System |
| Control Group | Placebo comparator | Device: Bionode IOP Lowering System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject ability and willingness to read, comprehend and signed the informed consent form.
- Subject willingness to comply with study instructions, agreement to make all office appointments, and complete the entire course of the study.
- Clinical diagnosis of primary open-angle glaucoma (POAG) or ocular hypertension (OHT) with IOP > 22 mmHg.
- Subjects > 22 years of age at the time of the screening examination.
- Central corneal thickness of > 450 µm and < 650 µm in study eye
Key exclusion criteria (19 listed)
- Angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
- Corneal endothelial dysfunction or abnormalities (e.g., Fuchs' Corneal Dystrophy) in either eye
- Known sensitivity to any products (e.g., contact lens) required for the study procedures
- A vertical cup to disc ratio of > 0.8, or notched optic nerve head rim in either eye
- Visual defect within 10 degrees of fixation or mean deviation of worse than -10 dB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bionode IOP Lowering SystemPatients wearing Bionode spectacles and customized contact lens and will receive stimulation at 50 Hz, 100 µs, up to 150 µA for 2 hours. | Device | Test Group |
| Bionode IOP Lowering SystemControl: No stimulation | Device | Control Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayda Shahidi, PhD study director
Prism Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionode IOP Lowering System in people with Unmedicated IOP Before and After Treatment, run by Bionode, LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Albors, MS (765-496-1827, goa@bionode.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (mmHg) (time frame: 0 min (baseline), 5 min, 30 min, 60 min, and 120 min post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.