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

Study Overview
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Brief Summary
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To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Olopatadine 0.1%
* Drug: Tranilast 0.5%
* Drug: Placebo (Olopatadine)
* Drug: Placebo (Tranilast)


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olopatadine 0.1% one eye<br>Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye | Drug: Olopatadine 0.1%<br>* one drop in one eye<br>|
| Experimental: Tranilast 0.5% one eye<br>Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye | Drug: Tranilast 0.5%<br>* one drop in one eye<br>|
| Placebo Comparator: Placebo (Olopatadine)<br>Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye | Drug: Placebo (Olopatadine)<br>* one drop in contralateral eye<br>|
| Placebo Comparator: Placebo (Tranilast)<br>Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye | Drug: Placebo (Tranilast)<br>* one drop in contralateral eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching. | 0-180 minutes after entering the examination room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Score in Ocular Symptom Questionnaire |  | 15-180 min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conjunctivitis