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

Last updated: October 5, 2015
Sponsor: Alcon Research
Overall Status: Completed

Phase

4

Condition

Eye Disorders/infections

Allergy

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT02251613
13-100-0009
UMIN000013943
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • History of hypersensitivity to the study drug or compounds;

  • Any ocular condition that, in the opinion of the investigator, could affect thepatient's safety;

  • Ocular surgical intervention within 3 months or refractive surgery within 6 monthsprior 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.

Study Design

Total Participants: 50
Study Start date:
December 01, 2013
Estimated Completion Date:
January 31, 2014