drugset / Trial / NCT00833495

Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation

NCT00833495

Phase 2 Completed 155 enrolled Fovea Pharmaceuticals SA
RandomizedFactorialDouble-blindTreatment

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

Timeline

Start
2009-01
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject FOV1101-00 Unknown Topical
Subject Prednisolone Other / unclassified 0.12 % Topical
Subject Prednisolone Other / unclassified 1 % Topical

Indications