A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01589510
First received: April 30, 2012
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: January 21, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Intervention: Drug: bimatoprost 0.01% ophthalmic solution

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lumigan® 0.01% Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.

Participant Flow:   Overall Study
    Lumigan® 0.01%  
STARTED     419  
COMPLETED     386  
NOT COMPLETED     33  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Lumigan® 0.01% Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.

Baseline Measures
    Lumigan® 0.01%  
Number of Participants  
[units: participants]
  419  
Age, Customized  
[units: Participants]
 
<18 years     0  
18 to 30 years     1  
31 to 40 years     7  
41 to 50 years     33  
51 to 60 years     66  
61 to 70 years     137  
71 to 80 years     116  
81 to 90 years     51  
>=91 years     4  
Missing     4  
Gender, Customized  
[units: Participants]
 
Female     232  
Male     183  
Missing     4  



  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   IOP at Week 14   [ Time Frame: Week 14 ]

3.  Secondary:   Physician Evaluation of IOP Lowering in the Study Eye(s)   [ Time Frame: Week 14 ]

4.  Secondary:   Patient Assessment of Tolerability on a 4-Point Scale   [ Time Frame: Week 14 ]

5.  Secondary:   Physician Assessment of Tolerability on a 4-Point Scale   [ Time Frame: Week 14 ]

6.  Secondary:   Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment   [ Time Frame: 14 Weeks ]

7.  Secondary:   Percentage of Patients Who Continue Lumigan® 0.01% Treatment   [ Time Frame: Week 14 ]

8.  Secondary:   Physician Assessment of Patient Compliance Compared to Previous Therapy   [ Time Frame: Week 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01589510     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/034
Study First Received: April 30, 2012
Results First Received: January 21, 2014
Last Updated: May 15, 2014
Health Authority: Austria: Ethikkommission