Phase 3
N=185
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01217606 ↗Enrolled (actual)
185
Serious AEs
1.1%
Results posted
Nov 2015
Primary outcome: Primary: Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test — 25.42; 24.43; -10.45; -8.28 Millimeters of Mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) (Drug); Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test |
25.42; 24.43; -10.45; -8.28 | — |
| SECONDARY Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure |
25.42; 24.43; -11.63; -8.13; -11.24; -8.12 | — |
| SECONDARY Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA) |
25.42; 24.43; -11.63; -8.13; -11.20; -8.28 | — |
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.
Eligibility 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 traumatic eye surgeries
- Cataract surgery in the past 6 months
- Anticipated wearing of contact lenses during the study
Data sourced from ClinicalTrials.gov (NCT01217606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.