Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198523
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2005-09-13
Brief Title:
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Sponsor:
Bausch Lomb Incorporated
Organization:
Bausch Lomb Incorporated
Study Overview
Official Title:
A Multi-Center Randomized Double Masked Bioequivalence Study of Tobramycin and Prednisolone Acetate 0310 ISTA Ophthalmic Suspension Compared to PredForte 10 Prednisolone Acetate Allergan Ophthalmic Suspension
Status:
COMPLETED
Status Verified Date:
2013-03
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:
The purpose of this study is to demonstrate the bioequivalence of the combination test agent prednisolone acetate 10 and tobramycin 03 ophthalmic suspension compared to PredForte prednisolone acetate 10 ophthalmic suspension Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate
Detailed Description:
None
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