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