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Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Olopatadine 0.1% (Drug); Tranilast 0.5% (Drug); Placebo (Olopatadine) (Drug); Placebo (Tranilast) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research


To evaluate the efficacy of olopatadine 0. 1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire

Secondary outcome: Change in Total Score in Ocular Symptom Questionnaire


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Age/Gender: males and females aged >20 to < 65 years (at the time of obtaining consent). 2. 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. 3. 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. 4. Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study. Exclusion Criteria: 1. Cases with an ocular disease that requires treatment other than allergic conjunctivitis. 2. Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation. 3. Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis. 4. Cases with past history of anaphylaxis. 5. Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast. 6. Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy). 7. Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period. 8. Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.

Locations and Contacts

Additional Information

Starting date: July 2008
Last updated: May 29, 2012

Page last updated: August 23, 2015

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