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Safety and Efficacy of Combigan® Ophthalmic Solution in Korea

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: NCT01987752
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.

Condition or disease Intervention/treatment
Glaucoma, Open-Angle Ocular Hypertension Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution

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Study Type : Observational
Actual Enrollment : 732 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
Combigan® Ophthalmic Solution
Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Drug: brimonidine tartrate/timolol maleate Ophthalmic Solution
brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice.
Other Name: Combigan®




Primary Outcome Measures :
  1. Percentage of Participants Reporting Adverse Events [ Time Frame: Up to 2.6 Years ]
    An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

  2. Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Week 4 ]
    IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution in Clinical practice.
Criteria

Inclusion Criteria:

  • Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice.

Exclusion Criteria:

  • None.

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): NCT01987752


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01987752     History of Changes
Other Study ID Numbers: 190342-040
First Posted: November 19, 2013    Key Record Dates
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Ocular Hypertension
Glaucoma, Open-Angle
Glaucoma
Eye Diseases
Timolol
Brimonidine Tartrate
Ophthalmic Solutions
Pharmaceutical Solutions
Brimonidine Tartrate, Timolol Maleate Drug Combination
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists