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

Phase 4

Completed

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

• Registration Number: NCT01978600
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Results First Submitted: 2015-03-31
• Results First Submitted QC: 2015-03-31
• Last Update Submitted: 2015-03-31
• Results First Posted: 2015-04-13
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol Maleate 0.5%	Timolol Maleate 0.5%	Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
SIMBRINZA™	Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension	Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks

Primary Outcome Measures

Name	Time	Method
Mean Nocturnal IOP at Week 4	Week 4: 10PM, 12AM, 2AM, 4AM, 6AM	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).

Secondary Outcome Measures

Name	Time	Method
Mean 24-hour IOP at Week 4	Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM	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).
Mean Diurnal IOP at Week 4	Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM	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).