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Safety and Efficacy of a Glaucoma Drug Delivery System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00824720
First received: January 9, 2009
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
Results First Received: April 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Interventions: Drug: High Dose Device
Drug: Low Dose Device
Device: Placebo Device

  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
High Dose Bimatoprost Punctal Plug punctal plug with bimatoprost, high dose
Low Dose Bimatoprost Punctal Plug punctal plug with bimatoprost, low dose
Placebo punctal plug without bimatoprost

Participant Flow:   Overall Study
    High Dose Bimatoprost Punctal Plug     Low Dose Bimatoprost Punctal Plug     Placebo  
STARTED     19 [1]   16 [2]   20  
COMPLETED     16     15     19  
NOT COMPLETED     3     1     1  
failed plug insertion                 3                 1                 0  
Protocol Violation                 0                 0                 1  
[1] 3 subjects in the high dose group did not receive device - unable to insert.
[2] 1 subject in the low dose group did not receive device - unable to insert.



  Baseline Characteristics
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Reporting Groups
  Description
High Dose Bimatoprost Punctal Plug punctal plug with bimatoprost, high dose
Low Dose Bimatoprost Punctal Plug punctal plug with bimatoprost, low dose
Placebo punctal plug without bimatoprost
Total Total of all reporting groups

Baseline Measures
    High Dose Bimatoprost Punctal Plug     Low Dose Bimatoprost Punctal Plug     Placebo     Total  
Number of Participants  
[units: participants]
 		  16     15     20     51  
Age [1]
[units: years]
Mean ± Standard Deviation 		  66.7  ± 13.4     64.6  ± 12.9     64.5  ± 10.6     65.2  ± 12.0  
Gender  
[units: participants]
 		       
Female     9     9     13     31  
Male     7     6     7     20  
[1] This baseline measure includes all subjects with a plug insertion.



  Outcome Measures
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1.  Primary:   Visual Acuity - Right Eye   [ Time Frame: at 14 days ]
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2.  Primary:   Visual Acuity - Left Eye   [ Time Frame: at 14 days ]
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3.  Secondary:   Intraocular Pressure (IOP)   [ Time Frame: from baseline to 14 days ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Brian Schwam MD/Director Clinical Affairs & Ocular Sciences
Organization: Vistakon
phone: 904-443-1482


No publications provided


Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00824720     History of Changes
Other Study ID Numbers: CR-1630
Study First Received: January 9, 2009
Results First Received: April 15, 2010
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration