Efficacy and Safety of Brinzolamide/Brimonidine Fixed Combination BID Compared to Brinzolamide BID Plus Brimonidine BID in Subjects With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension; Brinzolamide 10 mg/mL eye drops, suspension; Brimonidine 2 mg/mL eye drops, solution; Vehicle
Intervention description: Inactive ingredients used as a placebo for masking purposes
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions; Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 493.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: OAG; OHT

Summary:

      The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL /
      Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10
      mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to
      intraocular pressure (IOP)-lowering efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma or ocular hypertension insufficiently controlled on
             monotherapy or currently on multiple IOP-lowering medications;

          -  Mean IOP measurements within guidelines specified in the protocol. 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:

          -  Women of childbearing potential who are pregnant, test positive for pregnancy, intend
             to become pregnant during the study period, breast-feeding, or not in agreement to use
             adequate birth control methods throughout the study;

          -  Severe central visual field loss in either eye;

          -  Unable to safely discontinue all IOP-lowering ocular medication(s) for a minimum of 5
             (± 1) to 28 (± 1) days prior to E1 Visit;

          -  Chronic, recurrent or severe inflammatory eye disease;

          -  Ocular trauma within the past 6 months;

          -  Ocular infection or ocular inflammation within the past 3 months;

          -  Clinically significant 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 preclude the administration
             of α-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI);

          -  Intraocular surgery within the past 6 months;

          -  Ocular laser surgery within the past 3 months;

          -  Any abnormality preventing reliable applanation tonometry;

          -  Any conditions including severe illness which would make the Subject, in the opinion
             of the Investigator, unsuitable for the study;

          -  History of active, severe, unstable or uncontrolled cardiovascular, cerebrovascular,
             hepatic, or renal disease that would preclude safe administration of a topical
             α-adrenergic agonist or CAI;

          -  Recent (within 4 weeks of the E1 Visit) use of high-dose (> 1 g daily) salicylate
             therapy;

          -  Current or anticipated treatment with any psychotropic drugs that augment adrenergic
             response (eg, desipramine, amitriptyline);

          -  Concurrent use of monoamine oxidase inhibitors (MAOI);

          -  Concurrent use of glucocorticoids administered by any route;

          -  Therapy with another investigational agent within 30 days prior to the Screening
             Visit;

          -  Hypersensitivity to α-adrenergic agonist drugs, topical or oral CAIs, sulfonamide
             derivatives, or to any component of the study medications;

          -  Less than 30 days stable dosing regimen before the Screening Visit of any medications
             (excluding IOP-lowering treatments) or substances administered by any route and used
             on a chronic basis that may affect IOP, including but not limited to β-adrenergic
             blocking agents;

          -  Use of any additional topical or systemic ocular hypotensive medication during the
             study;

          -  Other protocol-specified exclusion criteria may apply.