Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT01229462

First received: October 26, 2010

Last updated: August 15, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 26, 2010

Last Updated Date

August 15, 2012

Start Date ^ICMJE

October 2010

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]

Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

Original Primary Outcome Measures ^ICMJE

Intraocular Pressure (IOP) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01229462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Official Title ^ICMJE

Not Provided

Brief Summary

This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Glaucoma
Ocular Hypertension

Intervention ^ICMJE

Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Other Name: Combigan®
Drug: brimonidine tartrate ophthalmic solution
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Other Name: Alphagan®
Drug: timolol ophthalmic solution
One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Other: fixed combination vehicle
Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Study Arm (s)

Combigan®
One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Interventions:
- Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution
- Other: fixed combination vehicle
Active Comparator: Alphagan® and Timolol Concurrent
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Interventions:
- Drug: brimonidine tartrate ophthalmic solution
- Drug: 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

Completed

Enrollment ^ICMJE

238

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
No anticipated wearing of contact lenses during study

Exclusion Criteria:

Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
Required regular use of other ocular medications except for occasional use of artificial tears

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01229462

Other Study ID Numbers ^ICMJE

190342-035

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

August 2012

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

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