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

Condition(s) targeted: Glaucoma, Open-Angle; Ocular Hypertension

Intervention: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) (Drug); Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Change From Baseline in Mean Worse Eye IOP

Mean Worse Eye IOP

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Bogotá, Colombia

Mexico City, Mexico

Starting date: March 2011
Last updated: September 4, 2014