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

This study is divided into two phases conducted in sequence. Phase I is the
Screening/Eligibility Phase, which includes a Screening Visit, followed by two Eligibility
Visits. Phase II is the randomized, double-masked, 6-week Treatment Phase which includes
on-therapy visits at Week 2 and Week 6.

Inclusion Criteria:

- Diagnosed with open-angle glaucoma (including open-angle glaucoma with
pseudoexfoliation or pigment dispersion) or ocular hypertension;

- IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean
IOP must not be >36 mmHG at any time point;

- Able to understand and sign an informed consent form;

- Other protocol-specified inclusion criteria may apply.

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;

- Other protocol-specified exclusion criteria may apply.