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

Sponsor:	Allergan
Information provided by (Responsible Party):	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%; latanoprost 0.005% Drug: timolol maleate 0.5%; latanoprost 0.005%	Phase IV

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Brimonidine Brimonidine tartrate Latanoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary 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 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 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.
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.
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® adjunctive to Xalatan®	Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%; latanoprost 0.005% 1 drop of study medication taken approximately 12 hours apart, up to 2 times a day. 1 drop of latanoprost once nightly. Other Names: Combigan® Xalatan®
Active Comparator: Timolol Timolol adjunctive to Xalatan®	Drug: timolol maleate 0.5%; latanoprost 0.005% 1 drop of study medication taken approximately 12 hours apart, up to 2 times a day. 1 drop of latanoprost once nightly. Other Names: Timpoptic® Timoptol® 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-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

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:	October 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
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 February 09, 2012