Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.

This study consisted of 6 visits conducted during 2 sequential phases: the Screening/Eligibility phase, which included a screening visit and 2 eligibility visits, and the Treatment phase, which included 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.

• Open-Angle Glaucoma
• Ocular Hypertension

• Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
• Drug: Brinzolamide ophthalmic suspension, 1%
  Other Name: AZOPT®
• Drug: Brimonidine tartrate ophthalmic solution, 0.2%

• Experimental: Brinzolamide/Brimonidine
  Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
  Intervention: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
• Active Comparator: Brinzolamide
  Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months
  Intervention: Drug: Brinzolamide ophthalmic suspension, 1%
• Active Comparator: Brimonidine
  Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months
  Intervention: Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Inclusion Criteria:

• Sign Informed Consent document.
• Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
• Any form of glaucoma other than open-angle glaucoma.
• Severe central vision loss in either eye.
• Chronic, recurrent, or severe inflammatory eye disease.
• Ocular trauma within the preceding 6 months.
• Ocular infection or ocular inflammation within the preceding 3 months.
• Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
• Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
• Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
• Ocular surgery within the preceding 6 months.
• Ocular laser surgery within the preceding 3 months.
• Any abnormality preventing reliable applanation tonometry.
• Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
• Other protocol-specified exclusion criteria may apply.