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

• ClinicalTrials.gov Identifier: NCT02251613
• Recruitment Status: Completed
• First Posted: September 29, 2014
• Results First Posted: February 9, 2015
• Last Update Posted: October 7, 2015
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Allergic Conjunctivitis	Drug: Olopatadine HCl ophthalmic solution, 0.1%; Drug: Epinastine HCl ophthalmic solution, 0.05%	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: December 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

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 Name: 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%

Outcome Measures

Primary Outcome Measures :

1. Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 [ Time Frame: 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 :

1. Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 [ Time Frame: 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).

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Tsunemitsu Senta; Alcon Japan, Ltd.

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02251613
• Other Study ID Numbers: 13-100-0009; UMIN000013943 ( Registry Identifier: UMIN )
• First Posted: September 29, 2014
• Results First Posted: February 9, 2015
• Last Update Posted: October 7, 2015
• Last Verified: October 2015

Additional relevant MeSH terms:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Olopatadine Hydrochloride; Pharmaceutical Solutions; Ophthalmic Solutions; Epinastine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action