Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328653
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2006-05-19
Brief Title:
Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis VKC
Sponsor:
Santen SAS
Organization:
Santen SAS
Study Overview
Official Title:
Phase IIIII Multicenter Double-Masked Randomized Parallel Group Dose Ranging Controlled Trial of Efficacy and Tolerance of Nova22007 Cyclosporine A CSA 005 01 Ophthalmic Cationic Emulsion Versus Vehicle in Patients With VKC
Status:
COMPLETED
Status Verified Date:
2021-11
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 primary objective of this study is
To assess the efficacy of Nova22007 a cyclosporine A CsA 005 and 01 versus vehicle in patients with vernal keratoconjunctivitis VKC after a 4-week treatment period
The secondary objectives of this study are
To compare the safety and ocular tolerance of Nova22007 005 and 01
To assess the long term safety and ocular tolerance of Nova22007 005 and 01 and
To assess the decrease in frequency of concomitant artificial tears use
To assess the efficacy of Nova22007 a cyclosporine A CsA 005 and 01 versus vehicle in patients with vernal keratoconjunctivitis VKC after a 4-week treatment period
The secondary objectives of this study are
To compare the safety and ocular tolerance of Nova22007 005 and 01
To assess the long term safety and ocular tolerance of Nova22007 005 and 01 and
To assess the decrease in frequency of concomitant artificial tears use
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