Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

Study Overview
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Brief Summary
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The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Olopatadine hydrochloride ophthalmic solution 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose parents or guardians can issue informed consent Patients aged over 7 and less than 16 at the baseline Patients confirmed to show type I allergy Patients with allergic conjunctivitis Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.) Exclusion Criteria: Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis Patients having retinal detachment, diabetic retinopathy or progressive retinal disease Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury Patients having received continuous treatment with corticosteroid within 3 months Patients having received immunotherapy Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for conjunctivitis or any ophthalmic solution other than the test product Patients having undergone ocular laser therapy within 3 months Unilaterally blind patients (best corrected visual acuity: below 0.01) Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride Patients necessitating the use of contact lens during the study period Other patients judged by the attending physician as inappropriate for study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olopatadine<br>Olopatadine hydrochloride ophthalmic solution 0.1% | Drug: Olopatadine hydrochloride ophthalmic solution 0.1%<br>* 1-2 drops 4 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 4 weeks | 
| Questionnaire about compliance with dosing instructions | (1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in score of subjective symptoms and objective findings | (0;none 1;mild 2;moderate 3;severe) | 4 weeks | 
| Questionnaire about stinging after instillation | (1;none 2;mild 3;moderate 4;severe) | 4 weeks | 

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