UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000040425
