Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 185
- Primary Endpoint
- Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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 up to 12 months.
Intervention: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) (Drug)
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 up to 12 months.
Intervention: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test
Time Frame: Baseline, Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed using a two-sample t-test.
Secondary Outcomes
- Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12)
- Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12)