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
  Purpose

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


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
Drug: latanoprost 0.005%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.


Enrollment: 148
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
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™
Active Comparator: 2
Latanoprost 0.005% ophthalmic solution
Drug: latanoprost 0.005%
1 drop of study medication taken once daily
Other Name: Xalatan™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811564

Locations
United States, New York
Slingerlands, New York, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Director, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00811564     History of Changes
Other Study ID Numbers: GMA-COM-08-008
Study First Received: December 17, 2008
Results First Received: August 17, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Latanoprost
Ophthalmic Solutions
Maleic acid
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on August 01, 2014