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

Alcon

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: Epinastine HCl ophthalmic solution, 0.05%; Drug: Olopatadine HCl ophthalmic solution, 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02251613

13-100-0009

UMIN000013943 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Olopatadine (right or left, randomized)

Experimental group

Description:

Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized

Treatment:

Drug: Olopatadine HCl ophthalmic solution, 0.1%

Epinastine (fellow eye)

Active Comparator group

Description:

Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye

Treatment:

Drug: Epinastine HCl ophthalmic solution, 0.05%