Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345046
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2006-06-26
Brief Title:
A Comparison of Three Different Formulations of Prednisolone Acetate 1
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1 for Control of Post Glaucoma andor Cataract Surgery Inflammation
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Generic prednisolone acetate 1 is less effective than Pred Forte 1 or Econopred Plus 1
Detailed Description:
Overall Study Design
Structure
This is a randomized double-masked prospective study The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital
Duration
Treatment duration The duration of each subjects participation will be for up to 2 months after surgery One hundred and two subjects will be enrolled over a twelve-month time span
Controls
Examiner staff and subjects are masked Parallel group comparison
DosageDose RegimenInstructions
Subjects scheduled for glaucoma andor 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
Structure
This is a randomized double-masked prospective study The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital
Duration
Treatment duration The duration of each subjects participation will be for up to 2 months after surgery One hundred and two subjects will be enrolled over a twelve-month time span
Controls
Examiner staff and subjects are masked Parallel group comparison
DosageDose RegimenInstructions
Subjects scheduled for glaucoma andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None