Clinical trial NCT01937312: Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Official title: Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ocular Hypertension
Open Angle Glaucoma
Keywords: glaucoma
prostaglandin analogue
brinzolamide
brimonidine
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-09-09
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.

Detailed description: This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
* Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and \<32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
* Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
* Able to understand and sign Informed Consent Document;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
* Any form of glaucoma other than open angle glaucoma or ocular hypertension;
* Severe central visual field loss;
* Chronic, recurrent, or severe inflammatory eye disease;
* Ocular trauma within the past 6 months;
* Ocular infection or ocular inflammation within the past 3 months;
* Best-corrected visual acuity score worse than approximately 20/80 Snellen;
* Eye surgery within the past 6 months;
* Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
* Use of any additional topical or systemic ocular hypertensive medication during the study;
* Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Diurnal Intraocular Pressure (IOP) at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Mean Diurnal IOP Change From Baseline to Week 6
timeFrame: Baseline, Week 6
measure: Mean Diurnal IOP Percentage Change From Baseline to Week 6
timeFrame: Baseline, Week 6
measure: Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
timeFrame: Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Steve Burmaster, PhD
role: STUDY_DIRECTOR
References: