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

Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Olopatadine HCl ophthalmic solution, 0.1%; Drug: Epinastine HCl ophthalmic solution, 0.05%

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olopatadine (right or left, randomized); Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized	Drug: Olopatadine HCl ophthalmic solution, 0.1%; Other Names: PATANOL®
Active Comparator: Epinastine (fellow eye); Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye	Drug: Epinastine HCl ophthalmic solution, 0.05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Ocular Itching at 7 Minutes Post-CAC, Day 1	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).	Day 1, 7 minutes post-CAC

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1	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).	Day 1, 20 minutes post-CAC

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Tsunemitsu Senta, Alcon Japan, Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Ophthalmic Solutions; Pharmaceutical Solutions; Olopatadine Hydrochloride; Epinastine
• Other Study ID Numbers: 13-100-0009; UMIN000013943 (Registry Identifier: UMIN)