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24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle (NCT02770248)

The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.
  • Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
    • SIMBRINZA ®
  • Drug: Vehicle
    Inactive ingredients used as a placebo for masking purposes
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Diagnosis of either open-angle glaucoma or ocular hypertension;
    • Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
    • Willing and able to sign an informed consent form;
    • Other protocol-specified inclusion criteria may apply.
    Exclusion Criteria:
    • Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
    • Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
    • Ocular surgeries or procedures excluded by the protocol;
    • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
    • Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
    • Other protocol-specific exclusion criteria may apply.
    Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.
    Participant Flow: Overall Study
    SIMBRINZA
    Vehicle
    Serious Adverse Events
    SIMBRINZA
    Vehicle
    Other Adverse Events
    SIMBRINZA
    Vehicle
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    22 May, 2016
    Updated:
    03 January, 2018
    Participants:
    162
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