Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134992
Status:
COMPLETED
Last Update Posted:
2006-06-09
First Post:
2005-08-24
Brief Title:
A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 05 Eye Drops Versus Vehicle in Healthy Volunteers
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Single-Center Randomized Double Masked Two-Period Cross-Over Three Days Per Period Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 05 Eye Drops Versus Vehicle in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2006-06
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 objective of this trial was to confirm the tolerability of prednisolone acetate 05 eye drops by testing the hypothesis that the ocular safety and tolerability of prednisolone acetate 05 eye drops are equivalent to vehicle Thus healthy volunteers have been selected and have been treated by using a crossover design
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