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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
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Ora
Andover, Massachusetts, United States
Start Date
January 1, 2009
Primary Completion Date
March 1, 2009
Completion Date
March 1, 2009
Last Updated
March 9, 2012
155
ACTUAL participants
Prednisolone Acetate 0.12% (Pred Mild®)
DRUG
FOV1101-00
DRUG
Prednisolone Acetate 1% (Pred Forte®)
DRUG
Placebo
DRUG
Lead Sponsor
Fovea Pharmaceuticals SA
NCT05839938
NCT05186025
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05191186