UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005931 |
|---|---|
| Receipt number | 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 20:12:20 |
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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
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
Sponsor or person
Institute
Alcon Japan Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007011
