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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Prednisolone Acetate 0.12% (Pred Mild®)
* Drug: FOV1101-00
* Drug: Prednisolone Acetate 1% (Pred Forte®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®) | Drug: Prednisolone Acetate 0.12% (Pred Mild®)<br>* 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.<br>Drug: FOV1101-00<br>* 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.<br>|
| Experimental: 2<br>FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®) | Drug: Prednisolone Acetate 0.12% (Pred Mild®)<br>* 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.<br>Drug: FOV1101-00<br>* 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.<br>|
| Experimental: 3<br>Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®) | Drug: Prednisolone Acetate 1% (Pred Forte®)<br>* 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.<br>Drug: Placebo<br>* The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.<br>|
| Placebo Comparator: 4<br>Vehicle of FOV1101-00 and vehicle of FOV1101-00 | Drug: Placebo<br>* The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Allergic signs and symptoms Diary Scores |  | Between V2 and V3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various ocular and nasal allergic diary scores |  | Between V2 and V3 |