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A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension (APOTUS)

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ClinicalTrials.gov Identifier: NCT02003534
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: 0.15% Brimonidine Tartrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013


Arm Intervention/treatment
Experimental: 0.15% Brimonidine Tartrate
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Drug: 0.15% Brimonidine Tartrate
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Other Name: Alphagan® P




Primary Outcome Measures :
  1. Change From Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Month 3 ]
    IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Used Alphagan® in previous 3 months

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): NCT02003534


Locations
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China
Shanghai, China
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02003534     History of Changes
Other Study ID Numbers: CN-BRI-1002
First Posted: December 6, 2013    Key Record Dates
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Brimonidine Tartrate
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs