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: VehicleInactive 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|
- 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.
- 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
Serious Adverse Events
Other Adverse Events
22 May, 2016
03 January, 2018