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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01109485
First received: April 12, 2010
Last updated: September 27, 2012
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Olopatadine hydrochloride ophthalmic solution 0.1%
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Questionnaire about compliance with dosing instructions [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    (1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%)


Secondary Outcome Measures:
  • Changes in score of subjective symptoms and objective findings [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    (0;none 1;mild 2;moderate 3;severe)

  • Questionnaire about stinging after instillation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    (1;none 2;mild 3;moderate 4;severe)


Enrollment: 42
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olopatadine
Olopatadine hydrochloride ophthalmic solution 0.1%
Drug: Olopatadine hydrochloride ophthalmic solution 0.1%
1-2 drops 4 times per day

  Eligibility

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01109485     History of Changes
Other Study ID Numbers: JPN-P-2010-1
Study First Received: April 12, 2010
Last Updated: September 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Institutional Review Board

Keywords provided by Alcon Research:
Allergic conjunctivitis

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

ClinicalTrials.gov processed this record on April 17, 2014