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

Alcon Research50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

Olopatadine HCl ophthalmic solution, 0.1%

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Day 1, 7 minutes post-CAC

Secondary Outcomes

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).

Time frame: Day 1, 20 minutes post-CAC