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

Information source: Fovea Pharmaceuticals SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Prednisolone Acetate 0.12% (Pred MildĀ®) (Drug); FOV1101-00 (Drug); Prednisolone Acetate 1% (Pred ForteĀ®) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Fovea Pharmaceuticals SA

Official(s) and/or principal investigator(s):
Jean-Philippe Combal, PharmD, Study Director, Affiliation: Fovea Pharmaceuticals SA


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 ForteĀ®

- Vehicle of FOV1101-00 and Vehicle of FOV1101-00

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Ocular Allergic signs and symptoms Diary Scores

Secondary outcome: Various ocular and nasal allergic diary scores


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- history of ocular allergies and a positive skin test reaction to allergens within

the past 24 months and a history of chronic eye irritation; Exclusion Criteria:

- active ocular infection; clinically significant blepharitis; follicular

conjunctivitis; iritis; any type of glaucoma; ocular surgery within past 3 months; pregnancy or nursing

Locations and Contacts

Ora, Andover, Massachusetts 01810, United States
Additional Information

Starting date: January 2009
Last updated: March 8, 2012

Page last updated: August 23, 2015

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