UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027156
Receipt number R000031121
Scientific Title Web-based survey on allergic diseases of the eye
Date of disclosure of the study information 2017/04/27
Last modified on 2024/02/15 13:14:21

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Basic information

Public title

Web-based survey on allergic diseases of the eye

Acronym

Web-based survey on allergic diseases of the eye

Scientific Title

Web-based survey on allergic diseases of the eye

Scientific Title:Acronym

Web-based survey on allergic diseases of the eye

Region

Japan


Condition

Condition

Allergic conjunctival disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.
Ask a questionnaire about allergic diseases for ophthalmologists and their families

Basic objectives2

Others

Basic objectives -Others

Prevalence

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence of allergic conjunctival disease
Relationship between allergic conjunctival disease and background of Patients

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

Ophthalmologists and their family members who give approval and answer questionnaires in the Web site.

Key exclusion criteria

not applicable

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Kazumi
Middle name
Last name Fukagawa

Organization

Japanese Ocular Allergology Society

Division name

-

Zip code

169-0075

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 Kazumi
Middle name
Last name Fukagawa

Organization

Japanese Ocular Allergology Society

Division name

-

Zip code

169-0075

Address

2-4-7, Takadanobaba, Shinjuku-ku, Tokyo 169-0075, Japan

TEL

03-5287-3801

Homepage URL


Email

joas_sec@staffroom.jp


Sponsor or person

Institute

Japanese Ocular Allergology Society

Institute

Department

Personal name



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

Medical Corporation Keishokai Ryogoku Ophthalmology Clinic Ethics Review Committee

Address

4-33-12 Ryogoku, Sumida-ku, Tokyo

Tel

03-5600-6886

Email

chisato-higashi@j-smo.com


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 04 Month 27 Day


Related information

URL releasing protocol

None

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/?term=Air+pollution+significantly+associated+with+severe+ocular+

Number of participants that the trial has enrolled

3014

Results

We obtained responses from 3004 cases (1498 males). Among systemic allergic diseases, allergic conjunctival disease was the most common (46.4%), followed by allergic rhinitis (34.1%), atopic dermatitis (7.8%), and asthma (5.8%). The prevalence of severe forms of atopic keratoconjunctivitis and spring catarrh were 5.5% and 1.3%, respectively.

Results date posted

2024 Year 02 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Refer to paper

Participant flow

Refer to paper

Adverse events

Not applicable due to web-based survey

Outcome measures

Prevalence of Allergic Conjunctivitis
Prevalence of severe allergic conjunctival lesions
Allergic Conjunctival Disease Associated with Various Study Subject Backgrounds

Plan to share IPD

The dataset is not publicly available.

IPD sharing Plan description

The dataset is not publicly available.


Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 03 Month 17 Day

Date of IRB

2017 Year 03 Month 27 Day

Anticipated trial start date

2017 Year 04 Month 06 Day

Last follow-up date

2017 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To understanding prevalence of allergic conjunctival disease


Management information

Registered date

2017 Year 04 Month 27 Day

Last modified on

2024 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name