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

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Olopatadine HCl ophthalmic solution, 0.1% (Drug); Epinastine HCl ophthalmic solution, 0.05% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Tsunemitsu Senta, Study Director, Affiliation: Alcon Japan, Ltd.

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: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Ocular Itching at 7 Minutes Post-CAC, Day 1

Secondary outcome: Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: December 2013
Last updated: January 26, 2015