Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

Phase 4

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension; Drug: Vehicle; Drug: Prostaglandin analogue

• Registration Number: NCT01937312
• Lead Sponsor: Alcon Research

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-09
• Study Start: 2013-10
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-22
• Results First Submitted QC: 2015-05-22
• Results First Posted: 2015-06-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Prostaglandin analogue	Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
SIMBRINZA	Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension	Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
SIMBRINZA	Prostaglandin analogue	Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Vehicle	Vehicle	Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks

Primary Outcome Measures

Name	Time	Method
Mean Diurnal Intraocular Pressure (IOP) at Week 6	Week 6	Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Secondary Outcome Measures

Name	Time	Method
Mean Diurnal IOP Percentage Change From Baseline to Week 6	Baseline, Week 6	Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.
Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)	Week 6	IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Mean Diurnal IOP Change From Baseline to Week 6	Baseline, Week 6	Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.