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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