24-hr Intraocular Pressure Control With SIMBRINZA ®

Alcon

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: Vehicle

Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT02770248

GLT320a-P001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.