Phase 4 N=125 Randomized Double-blind Treatment

24-hr Intraocular Pressure Control With SIMBRINZA ®

Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT02770248 ↗

Enrolled (actual)

125

Serious AEs

1.6%

Results posted

Jan 2018

Primary outcome: Primary: Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 — -3.09; -0.60 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension (Drug); Vehicle (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4	-3.09; -0.60	—
SECONDARY Least Squares Mean Change From Baseline in Daytime IOP at Week 4	-3.93; -0.51	—
SECONDARY Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4	-1.88; -0.73	—
SECONDARY Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4	-3.28; -0.49; -5.05; -0.61; -4.03; -0.27	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02770248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.