Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
NCT ID: NCT01109485
Last Updated: 2015-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2010-03-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Olopatadine
Olopatadine hydrochloride ophthalmic solution 0.1%
Olopatadine hydrochloride ophthalmic solution 0.1%
1-2 drops 4 times per day
Interventions
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Olopatadine hydrochloride ophthalmic solution 0.1%
1-2 drops 4 times per day
Eligibility Criteria
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Inclusion Criteria
* 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 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
7 Years
15 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Eriko Chono
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Contact Alcon Call Center For Trial Locations
Tokyo, , Japan
Countries
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Other Identifiers
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JPN-P-2010-1
Identifier Type: -
Identifier Source: org_study_id
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