24-hr Intraocular Pressure Control With SIMBRINZA ®



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/7/2017
Start Date:May 2016
End Date:January 14, 2017

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

The purpose of this study is to evaluate differences between treatments in mean change from
baseline in 24-hr IOP at Week 4.

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.

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.
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