Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
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: Active, not recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Summary
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.
Clinical Details
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: Intraocular Pressure (IOP)
Secondary outcome: IOPIOP IOP IOP IOP IOP IOP
Eligibility
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
Locations and Contacts
São Paulo, Brazil
Additional Information
Starting date: January 2011
Last updated: October 17, 2014
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