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A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01646151
First received: July 18, 2012
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: February 18, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Intervention: Drug: Bimatoprost

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bimatoprost Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.

Participant Flow:   Overall Study
    Bimatoprost
STARTED   2580 
COMPLETED   2410 
NOT COMPLETED   170 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bimatoprost Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.

Baseline Measures
   Bimatoprost 
Overall Participants Analyzed 
[Units: Participants]
 2580 
Age, Customized 
[Units: Participants]
 
<18 years   0 
18 to 30 years   12 
31 to 40 years   20 
41 to 50 years   178 
51 to 60 years   403 
61 to 70 years   695 
71 to 80 years   883 
81 to 90 years   342 
>=91 years   19 
Missing   28 
Gender, Customized 
[Units: Participants]
 
Female   1454 
Male   1115 
Missing   11 


  Outcome Measures
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1.  Primary:   Intraocular Pressure (IOP) at Baseline   [ Time Frame: Baseline ]

2.  Primary:   IOP at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Physician Evaluation of IOP Lowering in the Study Eye(s)   [ Time Frame: Week 12 ]

4.  Secondary:   Patient Assessment of Tolerability on a 4-Point Scale   [ Time Frame: Week 12 ]

5.  Secondary:   Physician Assessment of Tolerability on a 4-Point Scale   [ Time Frame: Week 12 ]

6.  Secondary:   Physician Assessment of Patient Compliance Compared to Previous Therapy   [ Time Frame: Week 12 ]

7.  Secondary:   Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment   [ Time Frame: 12 Weeks ]

8.  Secondary:   Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01646151     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/033
Study First Received: July 18, 2012
Results First Received: February 18, 2014
Last Updated: May 15, 2014
Health Authority: Germany: Ethics Commission