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

Phase 3

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution; Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)

• Registration Number: NCT01217606
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2011-01
• Primary Completion: 2014-09
• Study Completion: 2015-06
• Results First Submitted: 2015-10-12
• Results First Submitted QC: 2015-10-12
• Results First Posted: 2015-11-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combigan®	Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution	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.
Triple Combination Therapy	bimatoprost/brimonidine tartrate/timolol ophthalmic solution (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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test	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 Outcome Measures

Name	Time	Method
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	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 by a mixed-effect model for repeated measure.
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	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) 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 by ANCOVA.