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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833495
First Posted: February 2, 2009
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fovea Pharmaceuticals SA
  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
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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:


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 ]

Secondary Outcome Measures:
  • Various ocular and nasal allergic diary scores [ Time Frame: Between V2 and V3 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fovea Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT00833495     History of Changes
Other Study ID Numbers: 08-003-27
First Submitted: January 30, 2009
First Posted: February 2, 2009
Last Update Posted: March 9, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Inflammation
Conjunctivitis
Conjunctivitis, Allergic
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyclosporins
Cyclosporine
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents