A Comparison of Three Different Formulations of Prednisolone Acetate 1%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00345046
First received: June 26, 2006
Last updated: March 17, 2014
Last verified: March 2014
Results First Received: December 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma
Cataract
Interventions: Drug: Pred Forte
Drug: EconoPred Plus
Drug: Prednisolone Acetate

  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
Recruitment period Feb 2005 - Jun 2008 Subjects were recruited from surgical schedule.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was disqualified due to previous laser treatment. One subject did not receive study medication therefore was discontinued from study participation.

Reporting Groups
  Description
Pred Forte 1% Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
EconPred Plus 1% EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
Prednisolone Acetate 1% Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.

Participant Flow:   Overall Study
    Pred Forte 1%     EconPred Plus 1%     Prednisolone Acetate 1%  
STARTED     18     22     16  
COMPLETED     17     21     14  
NOT COMPLETED     1     1     2  
Protocol Violation                 1                 1                 2  



  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.
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Reporting Groups
  Description
Pred Forte

Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.

Pred Forte: Four drops daily decreasing to once daily over four weeks.

EconoPred Plus

EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.

EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks.

Prednisolone Acetate

Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.

Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks.

Total Total of all reporting groups

Baseline Measures
    Pred Forte     EconoPred Plus     Prednisolone Acetate     Total  
Number of Participants  
[units: participants]
  18     21     12     51  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 15.2     68.3  ± 13.0     65.7  ± 16.6     66.5  ± 14.5  
Gender  
[units: participants]
       
Female     10     8     7     25  
Male     8     13     5     26  



  Outcome Measures

1.  Primary:   Percent Change in Flare at Resolution   [ Time Frame: 2 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Louis B. Cantor
Organization: Indiana University
phone: 317-278-2651
e-mail: lcantor@iupui.edu


Publications:

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00345046     History of Changes
Other Study ID Numbers: 0201-28
Study First Received: June 26, 2006
Results First Received: December 24, 2013
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board