Clinical Trials

Inclusion Criteria: 

• Male or female subjects, ages ≥ 18 years  old.
• Able to provide signed written informed consent.
• Glaucoma in which the IOP is not controlled on current topical IOP-lowering glaucoma medication.
• Best-corrected baseline Snellen visual acuity of 20/100 or better.
• Visual field mean deviation no worse than -18.0 dB (with no dense paracentral scotomas; e.g., > 18 dB total deviation on 1 or more of the 4 paracentral points).
• Medicated IOP ≥ 15 mm Hg and ≤ 44 mm Hg on at least 1 topical IOP-lowering medication.
• Subjects not anticipated to require any other ocular surgery (e.g., cataract surgery) in either eye up to 3 months from the time of inclusion.
• Area of healthy, free, and mobile conjunctiva in the target area; i.e., superior bulbar conjunctiva.
• Visible trabecular meshwork with Shaffer angle grade ≥ 2 in the target area or, in eyes with prior failed angle surgery, an open angle in the target area.
• Preoperative laser trabeculoplasty is allowed 3 or more months prior to randomization.
• Failed ab-interno canal or suprachoroidal microinvasive glaucoma surgery (MIGS) procedures (such as iStentAb-interno ablative procedures (such as endoscopic cyclophotocoagulation [ECP]) are also allowed 3 or more months before enrollment. ®, gonioscopy-assisted transluminal trabeculotomy [GATT], ab-interno canaloplasty [ABiC™], Kahook Dual Blade goniotomy, etc) are allowed 3 or more months before enrollment, with the exception of CyPass® Micro-Stents, which are not allowed.

Exclusion Criteria: 

• Subject has active neovascular, uveitic, or angle-recession glaucoma or any glaucoma associated with vascular disorders.
• Subject has had prior ab-externo incisional glaucoma surgery (such as trabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.), conjunctival filtering surgery (such as XEN), transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation [UC3], etc) or prior major conjunctival surgery; i.e., scleral buckle.
• Clinically significant inflammation or infection within 30 days before the Preoperative Visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease, keratitis, uveitis, herpes simplex infection).
• Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target area.
• History of corneal surgery, corneal opacities, or corneal disease that could impact assessments/surgical outcomes in the study.
• Central corneal thickness ≤ 490 μm or ≥ 620 μm.
• Subjects on systemic carbonic anhydrase inhibitors (eg, Diamox® [acetazolamide] and Neptazane® [methazolamide]) at Baseline Qualifying Visit.
• Vitreous present in the anterior chamber.
• Aphakia.
• Subject has had prior intraocular surgery in either eye within ≤ 3 months before the Preoperative Visit (including phacoemulsification).
• History of complicated cataract surgery with visual impairment, vitreous loss, anterior chamber intraocular lens (ACIOL), sutured intraocular lens (IOL), scleral fixated IOL or cystoid macular edema (CME), dislocated IOL.
• Presence of intraocular silicone oil.
• Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or other ophthalmic disease or disorder that could confound study results or impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Rieger, iridocorneal endothelial [ICE] syndrome, etc.).
• Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components; e.g., bovine or porcine products, or glutaraldehyde.
• Pregnant or nursing women and those planning a pregnancy during the study period.
• Participation in another drug or device clinical trial that concludes within 30 days before the Preoperative Visit or that starts at any time during this study.