Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01151904
Recruitment Status : Terminated (Difficulty with patient recruitment)
First Posted : June 29, 2010
Results First Posted : February 6, 2013
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma, Angle-Closure Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution Drug: latanoprost Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: COMBIGAN® with Latanoprost
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
 Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution
COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.
Other Name: COMBIGAN®

Drug: latanoprost
Latanoprost administered in the affected eye(s) as prescribed by physician.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 12 ]
    IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.


Secondary Outcome Measures :
  1. Change From Baseline in IOP [ Time Frame: Baseline, Week 2, Week 6 ]
    IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.

  2. Percentage of Responders With an IOP Reduction ≥20% From Baseline [ Time Frame: Baseline, Week 12 ]
    IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
  • Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
  • Diagnosis of chronic angle-closure glaucoma
  • Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

Exclusion Criteria:

  • Known allergy or hypersensitivity to COMBIGAN®
  • Corneal abnormalities that would preclude accurate IOP readings
  • Any other active ocular disease other than glaucoma or ocular hypertension
  • Ocular surgery within the past 3 months.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151904


Locations
Layout table for location information
Thailand
Bangkok, Thailand
Sponsors and Collaborators
Allergan
Investigators
Layout table for investigator information
Study Director: Medical Director Allergan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01151904    
Other Study ID Numbers: MA-COM004
First Posted: June 29, 2010    Key Record Dates
Results First Posted: February 6, 2013
Last Update Posted: February 6, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Timolol
Brimonidine Tartrate
Ophthalmic Solutions
Latanoprost
Pharmaceutical Solutions
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists