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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251613
• Other study ID #: 13-100-0009
• Secondary ID: UMIN000013943
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2014
• Last updated: October 5, 2015
• Start date: December 2013
• Est. completion date: January 2014

Study information

• Verified date: October 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine HCl ophthalmic solution, 0.1%

• Epinastine HCl ophthalmic solution, 0.05%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No