A Comparison of Three Different Formulations of Prednisolone Acetate 1%
|Glaucoma Cataract||Drug: Pred Forte Drug: EconoPred Plus Drug: Prednisolone Acetate||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation.|
- Percent Change in Flare at Resolution [ Time Frame: 2 months ]
|Study Start Date:||September 2002|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345046
|United States, Indiana|
|IU Eye at Carmel|
|Indianapolis, Indiana, United States, 46290|
|Principal Investigator:||Louis B Cantor, MD||IUPUI/Clarian|