Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Brinzolamide/brimonidine vehicle; Travoprost 0.004%/timolol 0.5% solution
Intervention description: Inactive ingredients used as placebo comparator; 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Travoprost; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering
      effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to
      Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion
             glaucoma) or ocular hypertension.

          -  Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in
             the country, on morning or evening dosing for at least 28 days prior to screening, and
             in the opinion of the Investigator may benefit from further IOP lowering.

          -  Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least
             1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/
             Timolol 0.5% solution.

          -  Able to understand and sign an informed consent form that has been approved by an
             Institutional Review Board/Ethics Committee.

          -  Willing and able to attend all study visits.

        Exclusion Criteria:

          -  Women of childbearing potential: not postmenopausal for at least 1 year or less than 6
             weeks since sterilization, currently pregnant; have a positive result on the urine
             pregnancy test at Screening; intend to become pregnant during the study period;
             breast-feeding; or not in agreement to use adequate birth control methods to prevent
             pregnancy throughout the study.

          -  Mean IOP > 28 mmHg at any time point in either eye during the Screening/Eligibility
             Phase.

          -  Any form of glaucoma other than open-angle glaucoma or ocular hypertension.

          -  Severe central visual field loss in either eye.

          -  Chronic, recurrent or severe inflammatory eye disease in either eye.

          -  Ocular trauma in either eye within the past 6 months prior to the Screening visit.

          -  Ocular infection or ocular inflammation in either eye within the past 3 months prior
             to the Screening visit.

          -  Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.

          -  Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to
             approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye.

          -  Other ocular pathology (including severe dry eye) in either eye that may, in the
             opinion of the Investigator, preclude the safe administration of any study medication.

          -  Intraocular surgery in either eye within the past 6 months prior to the Screening
             visit.

          -  Ocular laser surgery in either eye within the past 3 months prior to the Screening
             visit.

          -  Any other condition including severe illness which would make the subject, in the
             opinion of the Investigator, unsuitable for the study.

          -  Asthma, history of asthma, or severe chronic obstructive pulmonary disease.