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

March 8, 2012 updated by: Fovea Pharmaceuticals SA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ocular Allergic signs and symptoms Diary Scores
Time Frame: Between V2 and V3
Between V2 and V3

Secondary Outcome Measures

Outcome Measure
Time Frame
Various ocular and nasal allergic diary scores
Time Frame: Between V2 and V3
Between V2 and V3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fovea Pharmaceuticals SA

Investigators

  • Study Director: Jean-Philippe Combal, PharmD, Fovea Pharmaceuticals SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

January 30, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-003-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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