An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00811564
First received: December 17, 2008
Last updated: August 17, 2011
Last verified: August 2011

December 17, 2008
August 17, 2011
December 2008
January 2010   (final data collection date for primary outcome measure)
Intraocular Pressure (IOP) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.
IOP [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00811564 on ClinicalTrials.gov Archive Site
Not Provided
Adverse Events [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Not Provided

A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
    1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day
    Other Name: Combigan™
  • Drug: latanoprost 0.005%
    1 drop of study medication taken once daily
    Other Name: Xalatan™
  • Active Comparator: 1
    Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
    Intervention: Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
  • Active Comparator: 2
    Latanoprost 0.005% ophthalmic solution
    Intervention: Drug: latanoprost 0.005%
Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Be at least 18 years of age;
  2. Give written informed consent;
  3. Be in good general health as determined by your doctor;
  4. Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
  5. If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
  6. Understand the study instructions, and be able to follow the study instructions; and
  7. Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

  1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
  2. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
  3. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00811564
GMA-COM-08-008
Not Provided
Medical Affairs Director, Allergan, Inc.
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
August 2011

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