6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Exclusion Criteria

• •Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;
• •Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit;
• •Chronic, recurrent or severe inflammatory eye disease;
• •Ocular trauma within the past 6 months prior to the Screening Visit;
• •Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit;
• •Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;
• •Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);
• •Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor;
• •Intraocular surgery within the past 6 months prior to the Screening Visit;
• •Ocular laser surgery within the past 3 months prior to the Screening Visit;
• •Any abnormality preventing reliable applanation tonometry;
• •Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
• •History of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;
• •Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator;
• •Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (\> 1 g daily) salicylate therapy;
• •Use of any additional topical or systemic ocular hypotensive medication during the study;
• •Concurrent use of glucocorticoids administered by any route;
• •Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents);
• •Therapy with another investigational agent within 30 days prior to the Screening Visit;