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

Purpose

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

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: Prednisolone Acetate 0.12% (Pred Mild®) Drug: FOV1101-00 Drug: Prednisolone Acetate 1% (Pred Forte®) Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Cyclosporine

U.S. FDA Resources

Further study details as provided by Fovea Pharmaceuticals SA:

Primary Outcome Measures:

Ocular Allergic signs and symptoms Diary Scores [ Time Frame: Between V2 and V3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Various ocular and nasal allergic diary scores [ Time Frame: Between V2 and V3 ] [ Designated as safety issue: No ]

Enrollment:	155
Study Start Date:	January 2009
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)	Drug: Prednisolone Acetate 0.12% (Pred Mild®) Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Drug: FOV1101-00 This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day.
Experimental: 2 FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)	Drug: Prednisolone Acetate 0.12% (Pred Mild®) Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Drug: FOV1101-00 This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day.
Experimental: 3 Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)	Drug: Prednisolone Acetate 1% (Pred Forte®) PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. Drug: Placebo The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.
Placebo Comparator: 4 Vehicle of FOV1101-00 and vehicle of FOV1101-00	Drug: Placebo The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833495

Locations

United States, Massachusetts
Ora
Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Fovea Pharmaceuticals SA

Investigators

Study Director:

Jean-Philippe Combal, PharmD

Fovea Pharmaceuticals SA

More Information

No publications provided

Responsible Party:	Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier:	NCT00833495 History of Changes
Other Study ID Numbers:	08-003-27
Study First Received:	January 30, 2009
Last Updated:	March 8, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
Inflammation
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Cyclosporins
Cyclosporine
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone

Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013