Phase 4 N=50 Randomized Double-blind Treatment

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

Allergic Conjunctivitis

Bottom Line

View on ClinicalTrials.gov: NCT02251613 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 — 0.23; 0.37 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Olopatadine HCl ophthalmic solution, 0.1% (Drug); Epinastine HCl ophthalmic solution, 0.05% (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Ocular Itching at 7 Minutes Post-CAC, Day 1	0.23; 0.37	—
SECONDARY Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1	0.89; 1.12	—

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02251613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.