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

This study is currently recruiting participants.

Verified May 2013 by Allergan

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT01241240

First received: November 12, 2010

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2010

Last Updated Date

May 13, 2013

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01241240 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

IOP [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

IOP [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma, Open-Angle
Ocular Hypertension

Intervention ^ICMJE

Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.

Other Name: COMBIGAN®

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

184

Estimated Completion Date

April 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Allergan Inc.

clinicaltrials@allerlgan.com

Location Countries ^ICMJE

Argentina, Colombia, Mexico

Administrative Information

NCT Number ^ICMJE

NCT01241240

Other Study ID Numbers ^ICMJE

192024-063

Has Data Monitoring Committee

Responsible Party

Allergan

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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