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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2009

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: 1
    • FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)
  • Experimental: 2
    • FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)
  • Experimental: 3
    • Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)
  • Placebo Comparator: 4
    • Vehicle of FOV1101-00 and vehicle of FOV1101-00

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fovea Pharmaceuticals SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Philippe Combal, PharmD, Study Director, Fovea Pharmaceuticals SA

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