UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035506
Receipt number R000040425
Scientific Title Prevalence and comorbidities of dry eye disease in eye clinic in Japan
Date of disclosure of the study information 2019/01/15
Last modified on 2020/03/27 13:42:27

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Basic information

Public title

Prevalence and comorbidities of dry eye disease in eye clinic in Japan

Acronym

Prevalence and comorbidities of dry eye disease in eye clinic in Japan

Scientific Title

Prevalence and comorbidities of dry eye disease in eye clinic in Japan

Scientific Title:Acronym

Prevalence and comorbidities of dry eye disease in eye clinic in Japan

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Do dry eye diagnosis for patients who visited the ophthalmologic clinic for a specific period and clarify the prevalence of dry eye.

Basic objectives2

Others

Basic objectives -Others

Consider the dry eye merger ratio for each other eye disease

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Dry eye prevalence in patients visited the study site.
Dry eye merger rate every other eye disease.

Key secondary outcomes



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

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Corneal and conjunctival fluorescein staining score

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

20 years of age or over
Regardless of sex

Key exclusion criteria

Subjects who cannot confirm subjective symptoms of dry eye
Subjects with hypersensitivity to fluorescein
Subjects who cannot perform fluorescein staining
Subjects who were judged ineligible by an investigator of this study.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Naruhiro
Middle name
Last name Ishida

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs, Development Management Department, Japan Business

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9603

Email

clinical@santen.co.jp


Public contact

Name of contact person

1st name Yoshiaki
Middle name
Last name Yamada

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs, Development Management Department, Japan Business

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9603

Homepage URL


Email

clinical@santen.co.jp


Sponsor or person

Institute

Santen Pharmaceutical Co., Ltd.

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 TOUKEIKAI Kitamachi Clinic ERB

Address

1, 3, Kichijoji Kita-cho, Musashino-shi, Tokyo

Tel

070-5011-8550

Email

shingo-namiki@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

2019 Year 01 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31728824

Number of participants that the trial has enrolled

1092

Results

The prevalence of dry eye disease was 55.7% in outpatients. It was also generally exceeded 50% in patients with other eye diseases.

Results date posted

2020 Year 03 Month 27 Day

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

2018 Year 12 Month 05 Day

Date of IRB

2018 Year 12 Month 18 Day

Anticipated trial start date

2019 Year 01 Month 15 Day

Last follow-up date

2019 Year 04 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective Multicenter Cross-Sectional Survey
Clarify the prevalence of dry eye in outpatients.


Management information

Registered date

2019 Year 01 Month 10 Day

Last modified on

2020 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040425


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name