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

NCT ID: NCT02251613

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-01-31

Brief 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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Olopatadine (right or left, randomized)

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

Group Type: EXPERIMENTAL

Olopatadine HCl ophthalmic solution, 0.1%

Intervention Type: DRUG

Epinastine (fellow eye)

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

Group Type: ACTIVE_COMPARATOR

Epinastine HCl ophthalmic solution, 0.05%

Intervention Type: DRUG

Interventions

Olopatadine HCl ophthalmic solution, 0.1%

Intervention Type: DRUG

Epinastine HCl ophthalmic solution, 0.05%

Intervention Type: DRUG

Other Intervention Names

PATANOL®

Eligibility 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;

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;

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsunemitsu Senta

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Other Identifiers

UMIN000013943

Identifier Type: REGISTRY

Identifier Source: secondary_id

13-100-0009

Identifier Type: -

Identifier Source: org_study_id