Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension; Vehicle; Brinzolamide 1% ophthalmic suspension; Brimonidine tartrate 0.2% ophthalmic solution
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: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: open-angle glaucoma; ocular hypertension; OAG; OHT

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the
             Investigator, are insufficiently controlled on monotherapy or are currently on
             multiple IOP-lowering medications.

          -  Meet qualifying IOP entry criteria.

          -  Able to understand and sign an informed consent form.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential if pregnant, test positive for pregnancy at Screening
             visit, breastfeeding, or not in agreement to use adequate birth control methods to
             prevent pregnancy throughout the study.

          -  Severe central visual field loss.

          -  Can not safely undergo the initial washout period and discontinue use of all
             IOP-lowering ocular medication(s) for the minimum specified period prior to
             Eligibility Visit 1.

          -  Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen
             equivalent).

          -  Chronic, recurrent or severe inflammatory eye disease.

          -  Ocular trauma within the preceding 6 months.

          -  Ocular infection or inflammation within the preceding 3 months.

          -  Clinically significant or progressive retinal disease.

          -  Other ocular pathology.

          -  Intraocular surgery within the 6 months prior to entry.

          -  Ocular laser surgery within the 3 months prior to entry.

          -  Any abnormality preventing reliable applanation tonometry.

          -  Any other conditions which would make the patient, in the opinion of the Investigator,
             unsuitable for the study.

          -  Recent use of high-dose (>1 gram daily) salicylate therapy.

          -  Recent, current, or anticipated treatment with any medication that augments adrenergic
             responses, or precludes use of an alpha-adrenergic agonist.

          -  Other protocol-specified exclusion criteria may apply.