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

Phase 4CompletedNCT01978600

Alcon Research89 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Open-Angle Glaucoma Ocular Hypertension

Interventions

Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspensionDRUG

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Timolol Maleate 0.5%DRUG

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM

Secondary Outcomes

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).

Time frame: 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).

Time frame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.