Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01229410
First received: October 20, 2010
Last updated: July 2, 2013
Last verified: July 2013
Results First Received: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Vitrectomy
Interventions: Drug: 400 µg Brimonidine Tartrate Implant
Drug: 200 µg Brimonidine Tartrate Implant

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were enrolled in groups by planned time of pars plana vitrectomy (Week 2, 4, or 8 post-implant). Patients who had the implant removed during the vitrectomy did not complete the 6 month follow-up per protocol.

Reporting Groups
  Description
400 µg Brimonidine Tartrate Implant 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
200 µg Brimonidine Tartrate Implant 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

Participant Flow:   Overall Study
    400 µg Brimonidine Tartrate Implant     200 µg Brimonidine Tartrate Implant  
STARTED     12     12  
COMPLETED     7     9  
NOT COMPLETED     5     3  



  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.
No text entered.

Reporting Groups
  Description
400 µg Brimonidine Tartrate Implant 400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
200 µg Brimonidine Tartrate Implant 200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Total Total of all reporting groups

Baseline Measures
    400 µg Brimonidine Tartrate Implant     200 µg Brimonidine Tartrate Implant     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: Years]
Mean ( Full Range )
  69.7  
  ( 64 to 75 )  
  66.5  
  ( 53 to 78 )  
  68.1  
  ( 53 to 78 )  
Gender  
[units: Participants]
     
Female     8     6     14  
Male     4     6     10  



  Outcome Measures
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1.  Primary:   Highest Vitreous Humor Level of Brimonidine in the Study Eye   [ Time Frame: 60 Days ]

2.  Secondary:   Highest Aqueous Humor Level of Brimonidine in the Study Eye   [ Time Frame: 60 Days ]

3.  Secondary:   Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)   [ Time Frame: 60 Days ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229410     History of Changes
Other Study ID Numbers: 190342-036
Study First Received: October 20, 2010
Results First Received: March 13, 2013
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration