Status:
COMPLETED
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan
Lead Sponsor:
Alcon Research
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 he...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02251613
Start Date
December 1 2013
End Date
January 1 2014
Last Update
October 7 2015
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