Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
Overview
The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2011
Interventions
- Drug: Olopatadine hydrochloride ophthalmic solution 0.1%
- 1-2 drops 4 times per day
Arms, Groups and Cohorts
- Experimental: Olopatadine
- Olopatadine hydrochloride ophthalmic solution 0.1%
Clinical Trial Outcome Measures
Primary Measures
- Incidence of adverse events
- Time Frame: 4 weeks
- Questionnaire about compliance with dosing instructions
- Time Frame: 4 weeks
- (1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%)
Secondary Measures
- Changes in score of subjective symptoms and objective findings
- Time Frame: 4 weeks
- (0;none 1;mild 2;moderate 3;severe)
- Questionnaire about stinging after instillation
- Time Frame: 4 weeks
- (1;none 2;mild 3;moderate 4;severe)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 7 Years
Maximum Age: 15 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Alcon Research
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Eriko Chono, Study Director, Alcon Research
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