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

NCT02251613 | Completed Phase 4 Results

• 2 other identifiers: 13-100-0009UMIN000013943
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1

  Day 1, 20 minutes post-CAC

Study Arms (2)

Olopatadine (right or left, randomized)

EXPERIMENTAL

Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized

Drug: Olopatadine HCl ophthalmic solution, 0.1%

Epinastine (fellow eye)

ACTIVE COMPARATOR

Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye

Drug: Epinastine HCl ophthalmic solution, 0.05%

Interventions

Olopatadine HCl ophthalmic solution, 0.1% DRUG

Also known as: PATANOL®

Olopatadine (right or left, randomized)

Epinastine HCl ophthalmic solution, 0.05% DRUG

Epinastine (fellow eye)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Hironari Sakaguchi, Phase IV Clinical & Regulatory Affairs, Japan
• Organization: Alcon Japan, Ltd.

Hironari.Sakaguchi@alcon.com

+81 3 6899 5054

Study Officials

• Tsunemitsu Senta

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 7, 2015
• Results First Posted: February 9, 2015

Record last verified: 2015-10