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 |
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.
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.
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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