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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01109485
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Olopatadine hydrochloride ophthalmic solution 0.1% Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Olopatadine
Olopatadine hydrochloride ophthalmic solution 0.1%
Drug: Olopatadine hydrochloride ophthalmic solution 0.1%
1-2 drops 4 times per day


Outcome Measures

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 4 weeks ]
  2. 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 Outcome Measures :
  1. Changes in score of subjective symptoms and objective findings [ Time Frame: 4 weeks ]
    (0;none 1;mild 2;moderate 3;severe)

  2. Questionnaire about stinging after instillation [ Time Frame: 4 weeks ]
    (1;none 2;mild 3;moderate 4;severe)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109485


Locations
Japan
Contact Alcon Call Center For Trial Locations
Tokyo, Japan, 1F
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Eriko Chono Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01109485     History of Changes
Other Study ID Numbers: JPN-P-2010-1
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: September 2011

Keywords provided by Alcon Research:
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action