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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007618
Receipt No. R000008848
Scientific Title The examination of the effect of tranilast eyedrop to severe allergic conjunctivitis
Date of disclosure of the study information 2012/04/02
Last modified on 2015/06/15

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Basic information
Public title The examination of the effect of tranilast eyedrop to severe allergic conjunctivitis
Acronym The examination of the effect of tranilast eyedrop to severe allergic conjunctivitis
Scientific Title The examination of the effect of tranilast eyedrop to severe allergic conjunctivitis
Scientific Title:Acronym The examination of the effect of tranilast eyedrop to severe allergic conjunctivitis
Region
Japan

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

Objectives
Narrative objectives1 The effect of Tranilast eye drops to the treatment of vernal keratoconjunctivitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The improvement of subjective and objectives signs
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria VKC patients who does not use steroid eye drops
Key exclusion criteria VKC patients who use steroid eye drops
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Ebihara
Organization Juntendo University School of Medicine
Division name Ophthalmology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email eyeofjun@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Ebihara
Organization Juntendo University School of Medicine
Division name Ophthalmology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1093
Homepage URL
Email eyeofjun@nifty.com

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Dept. of Ophthalmology, Juntendo University Urayasu Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2012 Year 04 Month 02 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 No longer recruiting
Date of protocol fixation
2012 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Improvement of visual acuity
Prospective study
Sampling for case control

Management information
Registered date
2012 Year 03 Month 30 Day
Last modified on
2015 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008848

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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