Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128245
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2005-08-05
Brief Title:
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A 24-week Randomized Double-blind Multicenter Parallel-group Placebo-controlled Evaluation of the Safety and Efficacy of 03 and 1 Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Status:
COMPLETED
Status Verified Date:
2014-01
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:
This study evaluates the efficacy and safety of 2 doses of pimecrolimus 03 and 1 ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca KCS dry eye syndrome patients
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