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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027367
Receipt No. R000031357
Scientific Title The current status of clinical practice and treatment for allergic conjunctival disease
Date of disclosure of the study information 2017/05/18
Last modified on 2017/11/16

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Basic information
Public title The current status of clinical practice and treatment for allergic conjunctival disease
Acronym The current status of clinical practice and treatment for allergic conjunctival disease
Scientific Title The current status of clinical practice and treatment for allergic conjunctival disease
Scientific Title:Acronym The current status of clinical practice and treatment for allergic conjunctival disease
Region
Japan

Condition
Condition Allergic conjunctival disease (ACD)
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Survey pathological condition, clinical entity, treatment of allergic conjunctival disease patients at ophthalmology in Japan.
Antigen test will be done for patients want to determine antigen.
Acquire patient background data on allergic conjunctival disease and expand it as evidence of epidemiology at the time of revision of the clinical practice guideline in the future and use it for the prevention and treatment of diseases.
Basic objectives2 Others
Basic objectives -Others Patient background, clinical entity, pathological condition, treatment of allergic conjunctival disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ratio of ACD in all patients
Current status of clinical practice and treatment
Background information of ACD patients
Change of symptoms score and observations score between first day and re-examination
Steroids combined use rate
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 1) Hospitalization or Outpatient : Outpatient (both first visit and re-examination possible)
2) Need anti-allergic treatment
3) Capable To answer JACQLQ Questionnaire (Japanese Allergic Conjunctival Disease Quality-of-Life Questionnaire)
Key exclusion criteria Not applicable
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Okamoto
Organization Japanese Ocular Allergology Society
Division name -
Zip code
Address 2-4-7, Takadanobaba, Shinjuku-ku, Tokyo 169-0075, Japan
TEL 03-5287-3801
Email joas_sec@staffroom.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Okamoto
Organization Japanese Ocular Allergology Society
Division name -
Zip code
Address 2-4-7, Takadanobaba, Shinjuku-ku, Tokyo 169-0075, Japan
TEL 03-5287-3801
Homepage URL
Email joas_sec@staffroom.jp

Sponsor
Institute Japanese Ocular Allergology Society
Institute
Department

Funding Source
Organization Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 05 Month 18 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate allergic conjunctival disease diagnosis and treatment

Management information
Registered date
2017 Year 05 Month 17 Day
Last modified on
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031357

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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