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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833495
• Other study ID #: 08-003-27
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2009
• Last updated: March 8, 2012
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: March 2012
• Source: Fovea Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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

Locations

Country	Name	City	State
United States	Ora	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fovea Pharmaceuticals SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Allergic signs and symptoms Diary Scores		Between V2 and V3	No
Secondary	Various ocular and nasal allergic diary scores		Between V2 and V3	No