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

Allergan192 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

192

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 12 weeks.

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 12 weeks.

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 prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit * Anticipated wearing of contact lenses during the study

Locations (2)

Unnamed facility

Bogotá, Colombia

Unnamed facility

Mexico City, Mexico

Outcomes

Primary Outcomes

Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12

IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Mean Worse Eye IOP

IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.

Time frame: Baseline, Weeks 1, 2, 4 and 8

Mean Worse Eye IOP

Time frame: Weeks 1, 2, 4, 8 and 12

Data from ClinicalTrials.gov

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