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  
Number of Participants  
[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