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Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSite Vision
ClinicalTrials.gov Identifier:
NCT01190878
First received: August 26, 2010
Last updated: June 2, 2016
Last verified: June 2016
Results First Received: April 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ocular Inflammation
Interventions: Drug: ISV-303
Drug: DuraSite Vehicle
Drug: Xibrom™

  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
No text entered.

Reporting Groups
  Description
ISV-303 BID ISV-303: 0.075% bromfenac in DuraSite dosed BID
ISV-303 QD ISV-303: 0.075% bromfenac in DuraSite dosed QD
Xibrom BID Xibrom™: 0.09% bromfenac dosed BID
DuraSite Vehicle BID DuraSite Vehicle: Vehicle dosed BID

Participant Flow:   Overall Study
    ISV-303 BID   ISV-303 QD   Xibrom BID   DuraSite Vehicle BID
STARTED   40   45   42   42 
COMPLETED   37   42   37   22 
NOT COMPLETED   3   3   5   20 



  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.
All randomized subjects

Reporting Groups
  Description
ISV-303 BID ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
ISV-303 QD ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
Xibrom BID Xibrom™: Xibrom dosed BID
DuraSite Vehicle BID DuraSite Vehicle: Vehicle Dosed BID
Total Total of all reporting groups

Baseline Measures
   ISV-303 BID   ISV-303 QD   Xibrom BID   DuraSite Vehicle BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   45   42   42   169 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.3  (7.70)   70.9  (9.75)   68.6  (10.49)   67.0  (9.30)   69.5  (9.47) 
Age, Customized 
[Units: Participants]
         
18-30 years   0   0   1   0   1 
31-50 years   0   0   0   2   2 
51-70 years   22   22   22   25   91 
>70 years   18   23   19   15   75 
Gender 
[Units: Participants]
         
Female   24   21   20   24   89 
Male   16   24   22   18   80 


  Outcome Measures

1.  Primary:   Ocular Inflammation   [ Time Frame: 15 days ]


  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: Director of Clinical Trials
Organization: InSite Vision
phone: 510-747-1269
e-mail: jhutcheson@insitevision.com



Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT01190878     History of Changes
Other Study ID Numbers: C-10-303-001
Study First Received: August 26, 2010
Results First Received: April 26, 2016
Last Updated: June 2, 2016
Health Authority: United States: Food and Drug Administration