A Study of LUMIGAN® RC in the Clinical Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01833741
First received: April 15, 2013
Last updated: September 24, 2013
Last verified: September 2013
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Intervention: Drug: Bimatoprost 0.01%

  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
No text entered.

Reporting Groups
  Description
Bimatoprost 0.01% Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Participant Flow:   Overall Study
    Bimatoprost 0.01%  
STARTED     1137  
COMPLETED     997  
NOT COMPLETED     140  



  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 0.01% Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Baseline Measures
    Bimatoprost 0.01%  
Number of Participants  
[units: participants]
  1137  
Age  
[units: Years]
Mean ± Standard Deviation
  66.7  ± 12.7  
Gender  
[units: Participants]
 
Female     605  
Male     532  



  Outcome Measures
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1.  Primary:   Percentage of Treatment-Naive Patients With Ocular Hyperemia   [ Time Frame: Week 12 ]

2.  Primary:   Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia   [ Time Frame: Week 12 ]

3.  Primary:   Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia   [ Time Frame: Week 12 ]

4.  Secondary:   Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients   [ Time Frame: Baseline, 12 Weeks ]

5.  Secondary:   Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients   [ Time Frame: Baseline, 12 Weeks ]

6.  Secondary:   Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy   [ Time Frame: Baseline, 12 Weeks ]

7.  Secondary:   Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients   [ Time Frame: Baseline, Week 6, Week 12 ]

8.  Secondary:   Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients   [ Time Frame: Baseline, Week 6, Week 12 ]

9.  Secondary:   Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy   [ Time Frame: Baseline, Week 6, Week 12 ]

10.  Secondary:   Percentage of Patients Discontinuing Due to Ocular Adverse Events   [ Time Frame: 12 Weeks ]


  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


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01833741     History of Changes
Other Study ID Numbers: CLEAR
Study First Received: April 15, 2013
Results First Received: July 9, 2013
Last Updated: September 24, 2013
Health Authority: Canada: Ethics Review Committee