Status:
COMPLETED
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Lead Sponsor:
Alcon Research
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
Eligibility Criteria
Inclusion
- Age/Gender: males and females aged \>20 to \< 65 years (at the time of obtaining consent).
- Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.
- Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.
- Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
Exclusion
- Cases with an ocular disease that requires treatment other than allergic conjunctivitis.
- Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.
- Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.
- Cases with past history of anaphylaxis.
- Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.
- Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).
- Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.
- Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00818805
Start Date
July 1 2008
Last Update
June 4 2012
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