Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.

Official Title
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Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Olopatadine HCl ophthalmic solution, 0.1%
* Drug: Epinastine HCl ophthalmic solution, 0.05%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be Japanese and live in Japan; History of allergic conjunctivitis; Positive skin test reaction to Japanese cedar at Visit 1; Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2; Able and willing to avoid all disallowed medications during the specified period; Able to discontinue wearing contact lenses during the specified period; Sign Informed Consent; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History of hypersensitivity to the study drug or compounds; Any ocular condition that, in the opinion of the investigator, could affect the patient's safety; Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study; Presence of active ocular infection; Use of disallowed medications as specified in the protocol; Pregnant, nursing, or planning to become pregnant during the study; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olopatadine (right or left, randomized)<br>Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized | Drug: Olopatadine HCl ophthalmic solution, 0.1%<br> <br> * Other names: PATANOL®;|
| Active Comparator: Epinastine (fellow eye)<br>Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye | Drug: Epinastine HCl ophthalmic solution, 0.05%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub). | Day 1, 7 minutes post-CAC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe). | Day 1, 20 minutes post-CAC |