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

This study has been completed.

Sponsor:

Information provided by:

Allergan

ClinicalTrials.gov Identifier:

NCT00332436

First received: May 30, 2006

Last updated: May 27, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 30, 2006
Last Updated Date	May 27, 2011
Start Date ^ICMJE	December 1999
Primary Completion Date	November 2001 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 30, 2006)	IOP
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00332436 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 Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with 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 Primary Purpose: Treatment
Condition ^ICMJE	Ocular Hypertension
Intervention ^ICMJE	Drug: brimonidine/timolol fixed combination
Study Arm (s)	Not Provided
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	586
Completion Date	November 2001
Primary Completion Date	November 2001 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes Patient requires IOP-lowering drug in both eyes Exclusion Criteria: Uncontrolled medical condition Contraindication to beta-adrenoceptor antagonist or brimonidine therapy
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00332436
Other Study ID Numbers ^ICMJE	190342-013T
Has Data Monitoring Committee	Not Provided
Responsible Party	Therapeutic Area Head, Allergan, Inc
Study Sponsor ^ICMJE	Allergan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Allergan
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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