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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:
NCT00652106
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 1, 2008
April 1, 2008
June 2003
March 2004   (final data collection date for primary outcome measure)
Intraocular pressure (IOP) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Not Provided

This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
    0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
    Other Name: COMBIGAN®
  • Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
    Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
  • Drug: Brimonidine 0.2% ophthalmic solution
    Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
    Other Name: ALPHAGAN®
  • Experimental: 1
    0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
    Intervention: Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
  • Active Comparator: 2
    Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
    Intervention: Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
  • Active Comparator: 3
    0.2% brimonidine ophthalmic solution
    Intervention: Drug: Brimonidine 0.2% ophthalmic solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
432
March 2004
March 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of ocular hypertension or glaucoma
  • Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00652106
190342-019T
Not Provided
Therapeutic Area Head, Allergan, Inc.
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
April 2008

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