Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-01 @ 12:15 PM
Study NCT ID:
NCT00833495
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2009-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation
Sponsor:
Fovea Pharmaceuticals SA
Organization:
Study Overview
Official Title:
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation
Status:
COMPLETED
Status Verified Date:
2012-03
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 is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:
* FOV1101-00 concentration 1 and Pred Mild®
* FOV1101-00 concentration 2 and Pred Mild®
* Vehicle of FOV1101-00 and Pred Forte®
* Vehicle of FOV1101-00 and Vehicle of FOV1101-00
* FOV1101-00 concentration 1 and Pred Mild®
* FOV1101-00 concentration 2 and Pred Mild®
* Vehicle of FOV1101-00 and Pred Forte®
* Vehicle of FOV1101-00 and Vehicle of FOV1101-00
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: