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Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
This study is currently recruiting participants.
Verified by Allergan, May 2009
First Received: August 13, 2008   Last Updated: May 13, 2009   History of Changes
Sponsor: Allergan
Information provided by: Allergan
ClinicalTrials.gov Identifier: NCT00735449
  Purpose

Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
Drug: timolol maleate 0.5%
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • IOP [ Time Frame: Baseline, Week 6, and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]
  • Patients who achieve 15% IOP reduction from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Combigan adjunctive to Xalatan
Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
1 drop of study medication taken approximately 12 hours apart, up to 2 times a day
2: Active Comparator
Timolol adjunctive to Xalatan
Drug: timolol maleate 0.5%
1 drop of study medication taken approximately 12 hours apart, up to 2 times a day

  Eligibility

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

Inclusion Criteria:

  • Be at least 18 years of age
  • Give written informed consent
  • Be in good general health as determined by your doctor
  • Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension
  • 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)
  • Understand the study instructions, and be able to follow the study instructions; and
  • Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits

Exclusion Criteria:

  • Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
  • History of severe renal or hepatic impairment
  • Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist
  • Contraindications to beta-andrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure
  • 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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735449

Contacts
Contact: Allergan Inc clinicaltrials@allergan.com

Locations
United States, New Jersey
Recruiting
Newark, New Jersey, United States
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan, Inc. ( Vice President Medical Affairs )
Study ID Numbers: GMA-COM-07-XTC
Study First Received: August 13, 2008
Last Updated: May 13, 2009
ClinicalTrials.gov Identifier: NCT00735449     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Pharmacologic Actions
Glaucoma
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Hypertension
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on February 08, 2010