Back to resultsEffectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Olopatadine HCl ophthalmic solution, 0.1%
Epinastine HCl ophthalmic solution, 0.05%
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Olopatadine (right or left, randomized)
Epinastine (fellow eye)
Arm Description
Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized
Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02251613
Brief Title
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olopatadine (right or left, randomized)
Arm Type
Experimental
Arm Description
Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized
Arm Title
Epinastine (fellow eye)
Arm Type
Active Comparator
Arm Description
Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye
Intervention Type
Drug
Intervention Name(s)
Olopatadine HCl ophthalmic solution, 0.1%
Other Intervention Name(s)
PATANOL®
Intervention Type
Drug
Intervention Name(s)
Epinastine HCl ophthalmic solution, 0.05%
Primary Outcome Measure Information:
Title
Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
Description
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).
Time Frame
Day 1, 7 minutes post-CAC
Secondary Outcome Measure Information:
Title
Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
Description
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).
Time Frame
Day 1, 20 minutes post-CAC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsunemitsu Senta
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan
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