Status:
UNKNOWN
Clinical Study Of The Bionode System In Subjects With Elevated IOP
Lead Sponsor:
Bionode, LLC
Conditions:
Unmedicated IOP Before and After Treatment
Eligibility:
All Genders
22+ years
Phase:
NA
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 c...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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)
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04093089
Start Date
July 17 2019
End Date
December 31 2020
Last Update
January 22 2020
Active Locations (1)
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1
Prism Eye Institue
Oakville, Ontario, Canada, L6H 0J8