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Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01201798
First received: September 13, 2010
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
Results First Received: August 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Endogenous Anterior Uveitis
Interventions: Drug: Difluprednate 0.05% ophthalmic emulsion
Drug: Prednisolone acetate 1.0% ophthalmic suspension

  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
Subjects were recruited from 21 US study sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This reporting group includes all randomized subjects: 110. One subject was enrolled but discontinued prior to receiving study medication, with treatment randomization unknown.

Reporting Groups
  Description
Durezol Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
Pred Forte Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period

Participant Flow:   Overall Study
    Durezol     Pred Forte  
STARTED     56     54  
COMPLETED     47     39  
NOT COMPLETED     9     15  
Adverse Event                 2                 0  
Lost to Follow-up                 3                 5  
Decision Unrelated to an Adverse Event                 1                 1  
Noncompliance                 1                 0  
Protocol Violation                 1                 1  
Treatment Failure                 1                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Durezol Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
Pred Forte Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
Total Total of all reporting groups

Baseline Measures
    Durezol     Pred Forte     Total  
Number of Participants  
[units: participants]
 		  56     54     110  
Age  
[units: years]
Mean ± Standard Deviation 		  49.8  ± 15.20     45.5  ± 18.29     47.7  ± 16.85  
Gender  
[units: participants]
 		     
Female     31     29     60  
Male     25     25     50  



  Outcome Measures
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1.  Primary:   Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14   [ Time Frame: Baseline (Day 0), Day 14 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14   [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points   [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 3

4.  Secondary:   Proportion of Subjects With Anterior Chamber Cell Grade of 0   [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 4

5.  Secondary:   Proportion of Subjects With Anterior Chamber Cell Count of 0   [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 5

6.  Secondary:   Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0   [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 6

7.  Secondary:   Proportion of Subjects With Anterior Chamber Cell Grade ≤1   [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 7

8.  Secondary:   Proportion of Subjects Who Discontinued Due to Lack of Efficacy   [ Time Frame: Time to Event ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points   [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits   [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
  Show Outcome Measure 10


  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
No text entered.  


Results Point of Contact:  
Name/Title: Head, Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01201798     History of Changes
Other Study ID Numbers: C-10-034
Study First Received: September 13, 2010
Results First Received: August 31, 2012
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration