UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035506
Receipt No. 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 (Ver. 13)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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
Institute Santen Pharmaceutical Co., Ltd.
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040425