Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Allergan185 enrolled

Overview

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

185

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)DRUG

One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.

Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solutionDRUG

One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ocular hypertension or primary open-angle glaucoma in each eye * Requires treatment with IOP-lowering medication in both eyes Exclusion Criteria: * Required chronic use of ocular medications during the study other than study medication * Use of any corticosteroids within 30 days * History of any traumatic eye surgeries * Cataract surgery in the past 6 months * Anticipated wearing of contact lenses during the study

Locations (1)

Unnamed facility

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed using a two-sample t-test.

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure

Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12

Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by ANCOVA.

Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12

Data from ClinicalTrials.gov

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