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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Epinastine; Olopatadine Hydrochloride; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.