Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01241240

Purpose

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Brimonidine Tartrate Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Intraocular Pressure (IOP) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IOP [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
IOP [ Time Frame: Week 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	184
Study Start Date:	March 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Triple Combination Therapy Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.	Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
Active Comparator: Combigan® Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.	Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks. Other Name: COMBIGAN®

Eligibility

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

Criteria

Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

Required chronic use of ocular medications during the study other than study medication
Use of any corticosteroids within 30 days
History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
Anticipated wearing of contact lenses during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241240

Contacts

Contact: Allergan Inc.

clinicaltrials@allerlgan.com

Locations

Argentina
	Not yet recruiting
Buenos Aires, Argentina
Colombia
	Not yet recruiting
Bogotá, Colombia
Mexico
	Recruiting
Mexico City, Federal District, Mexico

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

More Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01241240 History of Changes
Other Study ID Numbers:	192024-063
Study First Received:	November 12, 2010
Last Updated:	May 14, 2012
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks (COFEPRIS)

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Bimatoprost
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
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on May 23, 2012