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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine
Ophthalmic Solutions
Pharmaceutical Solutions
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014