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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


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
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