Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405496
Status:
COMPLETED
Last Update Posted:
2006-11-30
First Post:
2006-11-29
Brief Title:
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Sponsor:
Sirion Therapeutics Inc
Organization:
Sirion Therapeutics Inc
Study Overview
Official Title:
Phase 2a Study of 005 Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis Inluding Iritis Cyclitis Iridocyclitis and Panuveitis
Status:
COMPLETED
Status Verified Date:
2006-11
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 phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis
Detailed Description:
The primary objective was to investigate the efficacy and safety of 005 difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development in comparison with Rinderon solution containing 01 betamethasone sodium phosphate that has widely been used for treatment of postoperative inflammation uveitis etc as a steroid ophthalmic solution
The secondary objective was to establish the evaluation system for a dose-finding study
The secondary objective was to establish the evaluation system for a dose-finding study
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