Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution

• Registration Number: NCT01216943
• Lead Sponsor: Allergan

Brief Summary

This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Study Start: 2010-11
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-07
• Results First Submitted: 2013-07-16
• Results First Submitted QC: 2013-07-16
• Last Update Submitted: 2013-07-16
• Results First Posted: 2013-09-19
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Glaucoma and/or ocular hypertension in both eyes
• Requires IOP-lowering treatment in both eyes

Exclusion Criteria

• Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
• Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
• Use of oral, injectable or topical corticosteroids within 21 days
• Iridectomy or laser peripheral iridotomy in the study eye within 3 months
• Uncomplicated cataract surgery in the study eye within 6 months
• Incisional glaucoma surgery in the study eye within 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triple Combination Therapy	bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution	One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye	Baseline, Week 12	IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study 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).