Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension; Drug: Timolol Maleate 0.5%

Detailed Description

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
• Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
• Must sign an Informed Consent form.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
• Severe central visual field loss in either eye.
• Chronic, recurrent or severe inflammatory eye disease.
• Ocular trauma or ocular surgery within the past 6 months.
• Ocular infection or ocular inflammation within the past 3 months.
• Clinically significant or progressive retinal disease.
• Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
• Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
• Any medical condition that would preclude the safe administration of a topical beta-blocker.
• Cannot safely discontinue all glucocorticoids administered by any route.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIMBRINZA™; Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks	Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension; Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.; Other Names: SIMBRINZA™
Active Comparator: Timolol Maleate 0.5%; Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks	Drug: Timolol Maleate 0.5%; Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.; Other Names: TIMOPTIC™; TIMOPTIC-XE™; BETIMOL™; ISTALOL™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Nocturnal IOP at Week 4	Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).	Week 4: 10PM, 12AM, 2AM, 4AM, 6AM

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Diurnal IOP at Week 4	Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).	Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM
Mean 24-hour IOP at Week 4	24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).	Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Danyel Carr, MS, Alcon Research

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Estimate): April 13, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Ocular Hypertension; Open-Angle Glaucoma; Simbrinza™
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Carbonic Anhydrase Inhibitors; Timolol; Brimonidine Tartrate; Brinzolamide
• Other Study ID Numbers: M-13-037