Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00735449
First received: August 13, 2008
Last updated: November 13, 2012
Last verified: November 2012
  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%
Drug: timolol maleate 0.5%
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
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:
  • Mean Intraocular Pressure (IOP) at 10 AM at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.


Secondary Outcome Measures:
  • Mean Intraocular Pressure (IOP) at 10 AM at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

  • Mean Intraocular Pressure (IOP) at 8 AM at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.

  • Mean Intraocular Pressure (IOP) at 8 AM at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

  • Number of Subjects With Adverse Events [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).


Enrollment: 204
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Combigan ®
Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)
Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
Other Name: Combigan®
Drug: latanoprost 0.005%
1 drop of latanoprost 0.005% once nightly.
Other Name: Xalatan®
Active Comparator: Timolol Maleate 0.5%
Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Drug: timolol maleate 0.5%
1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
Other Names:
  • Timpoptic®
  • Timoptol®
Drug: latanoprost 0.005%
1 drop of latanoprost 0.005% once nightly.
Other Name: Xalatan®

  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-adrenoceptor 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00735449

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00735449     History of Changes
Other Study ID Numbers: GMA-COM-07-XTC
Study First Received: August 13, 2008
Results First Received: October 17, 2011
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Latanoprost
Maleic acid
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 21, 2014