Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR) | NCT00818805 | Trialant
CompletedInterventionalPhase 4Updated Jun 4, 2012
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
ClinicalTrials.gov ID
NCT00818805
Lead Sponsor
Alcon ResearchINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
50Actual
Last Update Posted
Jun 4, 2012Estimated
Start Date
Jul 2008
Primary Completion Date
Jul 2008Actual
Brief Summary
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
Allergic Conjunctivitis
Olopatadine 0.1%
Tranilast 0.5%
Placebo (Olopatadine)
Placebo (Tranilast)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.