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: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy); Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution

• Registration Number: NCT01241240
• 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: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-16
• Study Start: 2011-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-09
• Results First Submitted: 2014-09-04
• Results First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Results First Posted: 2014-09-10
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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 12 weeks.
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 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12	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 Outcome Measures

Name	Time	Method
Mean Worse Eye IOP	Weeks 1, 2, 4, 8 and 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 each time-point.
Change From Baseline in Mean Worse Eye IOP	Baseline, Weeks 1, 2, 4 and 8	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 each visit. A negative change from Baseline indicated improvement.