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

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine HCl ophthalmic solution, 0.1%; Drug: Epinastine HCl ophthalmic solution, 0.05%

• Registration Number: NCT02251613
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-29
• Results First Submitted: 2015-01-26
• Results First Submitted QC: 2015-01-26
• Results First Posted: 2015-02-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olopatadine (right or left, randomized)	Olopatadine HCl ophthalmic solution, 0.1%	Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized
Epinastine (fellow eye)	Epinastine HCl ophthalmic solution, 0.05%	Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye

Primary Outcome Measures

Name	Time	Method
Mean Ocular Itching at 7 Minutes Post-CAC, Day 1	Day 1, 7 minutes post-CAC	A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).

Secondary Outcome Measures

Name	Time	Method
Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1	Day 1, 20 minutes post-CAC	A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).