Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Overview
- Phase
- Phase 3
- Intervention
- bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
- Conditions
- Glaucoma, Open-Angle
- Sponsor
- Allergan
- Enrollment
- 192
- Primary Endpoint
- Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
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 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
Arms & Interventions
Triple Combination Therapy
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Intervention: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
Combigan®
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Intervention: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Outcomes
Primary Outcomes
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12
Time Frame: Baseline, 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.
Secondary Outcomes
- Mean Worse Eye IOP(Weeks 1, 2, 4, 8 and 12)
- Change From Baseline in Mean Worse Eye IOP(Baseline, Weeks 1, 2, 4 and 8)