Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353964
Status:
UNKNOWN
Last Update Posted:
2006-07-28
First Post:
2006-07-17
Brief Title:
Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery
Sponsor:
Evolutec Group
Organization:
Evolutec Group
Study Overview
Official Title:
A Multi-Center Randomized Double Masked Placebo and Active Controlled Parallel-Group Study Evaluating the Safety and Efficacy of rEV131 25 MgmL rEV131 125 MgmL rEV131 0625 MgmL for the Treatment of Ocular Inflammation After Cataract Surgery
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131 a new investigational anti-inflammatory agent compared to placebo an inactive substance and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation
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