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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

Tracking Information
First Submitted Date  ICMJE December 2, 2013
First Posted Date  ICMJE December 6, 2013
Results First Submitted Date  ICMJE June 24, 2014
Results First Posted Date  ICMJE July 22, 2014
Last Update Posted Date July 22, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Month 3 ]
Change History Complete list of historical versions of study NCT02003534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension
Official Title  ICMJE Not Provided
Brief Summary This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 0.15% Brimonidine Tartrate
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Intervention: Drug: 0.15% Brimonidine Tartrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2014)
376
Original Actual Enrollment  ICMJE
 (submitted: December 2, 2013)
459
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Used Alphagan® in previous 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02003534
Other Study ID Numbers  ICMJE CN-BRI-1002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP