A Comparison of Three Different Formulations of Prednisolone Acetate 1%
|Study Design:||Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment|
Drug: Pred Forte
Drug: EconoPred Plus
Drug: Prednisolone Acetate
|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.|
|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.|
|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%|
|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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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 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 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|
|Pred Forte||EconoPred Plus||Prednisolone Acetate||Total|
Number of Participants
Mean ± Standard Deviation
|64.8 ± 15.2||68.3 ± 13.0||65.7 ± 16.6||66.5 ± 14.5|
|1. Primary:||Percent Change in Flare at Resolution [ Time Frame: 2 months ]|
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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|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:
Organization: Indiana University
|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