UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005931
Receipt No. R000007011
Scientific Title Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients
Date of disclosure of the study information 2011/07/05
Last modified on 2011/07/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients
Acronym Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients
Scientific Title Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients
Scientific Title:Acronym Clinical evaluation of 0.1% olopatadine hydrochloride ophthalmic solution in pediatric patients
Region
Japan

Condition
Condition allergic conjunctivits
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to verify safety and examine subjective symptoms and objective findings in children with allergic conjunctival diseases receiving Patanol Ophthalmic Solution 0.1% in the test eye (1-2 drops/dose) four times a day (morning, noon, evening and bedtime) for a period of 4 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Safety:
Presence/absence of adverse reactions
Efficacy:
Alleviation in subjective symptoms and objective findings
Key secondary outcomes Safety:
Compliance with dosing instructions (checked by interview of subjects during visit)
Efficacy:
Impressions after doses (checked by interview of subjects during visit)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patanol Ophthalmic Solution 0.1%
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
7 years-old <=
Age-upper limit
16 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients whose parents or other guardians can issue informed consent in writing prior to the study
2.Patients aged over 7 and less than 16 at the baseline
3.Patients confirmed to show type I allergy by skin reaction tests (intracutaneous test, scratch test, etc.), antigen-specific IgE antibody assay, neutrophhils in ocular discharge/conjunctival brushing specimen, and so on
4.Patients having inflammatory changes in the conjunctiva
5.Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)
Key exclusion criteria 1.Patients having ocular itching sensation and injection (caused by disease other than allergic conjunctivitis) possibly affecting the evaluation of drug efficacy
2.Patients having retinal detachment, diabetic retinopathy or progressive retinal disease (excluding cases rated by the attending physician as causing no problem in enrollment to the study)
3.Patients with a history of ocular infection (bacterial, viral or fungal), corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury (excluding cases rated by the attending physician as causing no problem in enrollment to the study)
4.Patients having received continuous treatment with corticosteroid (subconjunctival injection) within 3 months (90 days) before acquisition of consent
5.Patients having received immunotherapy (desensitization, immunomodulating therapy, etc.)
6.Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herb preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
7.Patients having undergone ocular laser therapy within 3 months (90 days) before acquisition of consent or non-laser ocular surgery within 6 months (180 days) after acquisition of consent or planned to receive surgery during the study period
8.Unilaterally blind patients (best corrected visual acuity: below 0.01)
9.Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
10.Patients necessitating the use of contact lens during the study period
11.Other patients judged by the attending physician as inappropriate for the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miki Uchino
Organization Ryogoku Eye Clinic
Division name Ophthalmology director
Zip code
Address 4-33-12 Ryogoku Sumida-ku Tokyo, JAPAN
TEL 03-5600-6886
Email

Public contact
Name of contact person
1st name
Middle name
Last name Miki Uchino
Organization Ryogoku Eye Clinic
Division name Ophthalmology Director
Zip code
Address 4-33-12 Ryogoku Sumida-ku Tokyo, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Alcon Japan Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Fujishima eye clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 05 Day
Last modified on
2011 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007011

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.