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Completed

NCT Number: NCT01109485

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

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center For Trial Locations

Tokyo, 1F, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olopatadine hydrochloride ophthalmic solution 0.1%

Drug

1-2 drops 4 times per day

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 23, 2010
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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