Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

Exclusion Criteria

• •Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
• •Prior stent implantations (study eye)
• •Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
• •Functionally significant visual field loss, including severe nerve fiber bundle defects
• •Prior incisional glaucoma surgery
• •Prior SLT within 90 days prior to screening
• •Prior ALT
• •Iridectomy or laser iridotomy
• •Ineligibility for ocular hypotensive medication washout period as determined by the investigator.
• •Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
• •Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata
• •Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability
• •Corneal opacities that would inhibit visualization of the nasal angle
• •Congenital or traumatic cataract
• •Retinal or optic nerve disorders that are not associated with the existing glaucoma condition
• •Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease
• •Clinically significant sequelae from trauma
• •Chronic ocular inflammatory disease or presence of active ocular inflammation
• •Subject did not complete medication washout
• •Mean IOP \< 22 mmHg or \> 38 mmHg after anti-glaucoma medication washout
• •Subject does not have a 3mmHg IOP increase over screening mean diurnal