Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.

Official Title
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A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Mild Ongoing Ocular Allergic Inflammation

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: CsA high dose
* Drug: CsA low dose
* Drug: PA
* 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 perennial allergens within the past 24 months and a history of chronic eye irritation visual acuity score ≥ 0.60 (EDTS) negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period. Exclusion Criteria: active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing contraindications or known allergies to the study drug(s)

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine low dose , Prednisolone Acetate<br>Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate | Drug: CsA low dose<br>* Solution of Cyclosporine (low dose) administered during 28 days<br>Drug: PA<br>* Suspension of Prednisolone Acetate administered during 28 days<br>|
| Experimental: Cyclosporine high dose, Prednisolone Acetate<br>Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate | Drug: CsA high dose<br>* Solution of Cyclosporine (high dose) administered during 28 days<br>Drug: PA<br>* Suspension of Prednisolone Acetate administered during 28 days<br>|
| Experimental: Cyclosporine high dose<br>Administration of a solution of Cyclosporine (high dose) and Placebo | Drug: CsA high dose<br>* Solution of Cyclosporine (high dose) administered during 28 days<br>Drug: Placebo<br>* Placebo solution administered during 28 days<br>|
| Experimental: Cyclosporine low dose<br>Administration of a solution of Cyclosporine (low dose) and Placebo | Drug: CsA low dose<br>* Solution of Cyclosporine (low dose) administered during 28 days<br>Drug: Placebo<br>* Placebo solution administered during 28 days<br>|
| Active Comparator: Prednisolone Acetate<br>Administration of a suspension of Prednisolone Acetate and Placebo | Drug: PA<br>* Suspension of Prednisolone Acetate administered during 28 days<br>|
| Placebo Comparator: Placebo<br>Administration of Placebo | Drug: Placebo<br>* Placebo solution administered during 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diary assessment of signs and symptoms of ocular allergy | Patient-reported ocular itching and redness | During the 28 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diary and office assessments of various ocular and nasal allergy signs and symptoms | Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching Investigator assessments of ocular redness and chemosis | During 28 days of treatment | 
| Safety | Ocular tolerance and adverse events | During the 28 days of treatment |