A Comparison of Three Different Formulations of Prednisolone Acetate 1%
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|ClinicalTrials.gov Identifier: NCT00345046|
Recruitment Status : Completed
First Posted : June 27, 2006
Results First Posted : April 21, 2014
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma Cataract||Drug: Pred Forte Drug: EconoPred Plus Drug: Prednisolone Acetate||Phase 4|
Overall Study Design:
This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.
Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery. One hundred and two subjects will be enrolled over a twelve-month time span.
Examiner, staff, and subjects are masked. Parallel group comparison.
Subjects scheduled for glaucoma and/or cataract surgery will be recruited. Subjects may not be currently on any steroid or ophthalmic non-steroidal anti-inflammatory (NSAID) therapy for a minimum of 6 weeks prior to surgery. Subjects will be randomized to receive a dose of Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon) four times a day starting immediately after finishing the surgery for two weeks, then twice a day for two more weeks. After 1 month of therapy subjects will stop or continue steroid treatment based on clinical findings. No other subconjunctival steroid or ointment will be used intra-operatively or post-operatively. The eye drop will be instilled per labeling instructions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Active Comparator: Pred Forte 1%
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
Drug: Pred Forte
Four drops daily decreasing to once daily over four weeks.
Other Name: Econopred Plus
Active Comparator: EconoPred Plus 1%
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
Drug: EconoPred Plus
Prednisolone Acetate four times daily decreasing to once daily over four weeks.
Other Name: Pred Forte
Active Comparator: Prednisolone Acetate 1%
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Drug: Prednisolone Acetate
Dosed four times daily decreasing to once daily over four weeks.
- Percent Change in Flare at Resolution [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345046
|United States, Indiana|
|IU Eye at Carmel|
|Indianapolis, Indiana, United States, 46290|
|Principal Investigator:||Louis B Cantor, MD||IUPUI/Clarian|