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

NCT ID: NCT00833495

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-03-31

Brief 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 Forte®
• Vehicle of FOV1101-00 and Vehicle of FOV1101-00

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)

Group Type: EXPERIMENTAL

Prednisolone Acetate 0.12% (Pred Mild®)

Intervention Type: DRUG

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.

FOV1101-00

Intervention Type: DRUG

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.

2

FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)

Group Type: EXPERIMENTAL

Prednisolone Acetate 0.12% (Pred Mild®)

Intervention Type: DRUG

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.

FOV1101-00

Intervention Type: DRUG

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.

3

Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)

Group Type: EXPERIMENTAL

Prednisolone Acetate 1% (Pred Forte®)

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.

4

Vehicle of FOV1101-00 and vehicle of FOV1101-00

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fovea Pharmaceuticals SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe Combal, PharmD

Role: STUDY_DIRECTOR

Fovea Pharmaceuticals SA

Locations

Ora

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

08-003-27

Identifier Type: -

Identifier Source: org_study_id