Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Inclusion Criteria:

• Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
• Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
• Must sign an Informed Consent form.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
• Severe central visual field loss in either eye.
• Chronic, recurrent or severe inflammatory eye disease.
• Ocular trauma or ocular surgery within the past 6 months.
• Ocular infection or ocular inflammation within the past 3 months.
• Clinically significant or progressive retinal disease.
• Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
• Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
• Any medical condition that would preclude the safe administration of a topical beta-blocker.
• Cannot safely discontinue all glucocorticoids administered by any route.
• Other protocol-specified exclusion criteria may apply.