UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058502 |
|---|---|
| Receipt number | R000066875 |
| Scientific Title | Epidemiological study to estimate the disease burden in quality of life (QOL), work productivity and treatment satisfaction for patients with dry eye disease using questionnaires linked with claims data in Japan. |
| Date of disclosure of the study information | 2025/07/17 |
| Last modified on | 2025/07/17 16:21:34 |
* 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
Epidemiological study to estimate the disease burden in quality of life (QOL), work productivity and treatment satisfaction for patients with dry eye disease using questionnaires linked with claims data in Japan.
Acronym
Epidemiological study to estimate the disease burden in quality of life (QOL), work productivity and treatment satisfaction for patients with dry eye disease using questionnaires linked with claims data in Japan.
Scientific Title
Epidemiological study to estimate the disease burden in quality of life (QOL), work productivity and treatment satisfaction for patients with dry eye disease using questionnaires linked with claims data in Japan.
Scientific Title:Acronym
Epidemiological study to estimate the disease burden in quality of life (QOL), work productivity and treatment satisfaction for patients with dry eye disease using questionnaires linked with claims data in Japan.
Region
| Japan |
Condition
Condition
Dry eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the EQ-5D-5L and WPAI scores in patients with dry eye disease (DED), stratified by severity of DED and DED on-label treatment.
Basic objectives2
Others
Basic objectives -Others
To estimate the economic burden of dry eye disease (DED) based on its prevalence and associated productivity losses.
To identify risk factors associated with DED.
To assess treatment satisfaction with prescription and over-the-counter (OTC) medications for DED.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
There are no outcomes because this an exploratory research
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
Patients who register kencom application and complete the entire questionnaire between November 1, 2024, and November 30, 2024.
Key exclusion criteria
Patients who meet any of the following criteria are excluded:
Patients whose demographics (age, sex, etc.) from claims data are inconsistent with those obtained from the questionnaire data.
Patients who do not have 6 months of continuous enrollment (ie. individuals are enrolled in the database between April 1, 2024 and November 1, 2024) before November 1, 2024.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Shirai |
| Middle name | |
| Last name | Chikako |
Organization
Viatris Pharmaceuticals Japan G.K.
Division name
Media Affairs Department
Zip code
106-0041
Address
1-3-1 Azabudai, Minato-ku, Tokyo
TEL
03-5656-0400
Chikako.Shirai@viatris.com
Public contact
Name of contact person
| 1st name | Uchino |
| Middle name | |
| Last name | Shota |
Organization
DATACK Inc.
Division name
Real World Data Research Strategy Division
Zip code
102-0072
Address
707, 1-8-9, Iidabashi Chiyoda-ku, Tokyo Japan
TEL
03-6775-4814
Homepage URL
kanri@datack.jp
Sponsor or person
Institute
Viatris Pharmaceuticals Japan G.K.
Institute
Department
Personal name
Funding Source
Organization
Viatris Pharmaceuticals Japan G.K.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Dry Eye Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
CMIC HealthCare Institute Co.,Ltd.
Address
#17F Hamamatsucho Building Shibaura, Minato-ku, Tokyo-to 105-0023 Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
| 2025 | Year | 07 | Month | 17 | 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
20000
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data period used in this study spans from April 1, 2014, to March 31, 2023.
Management information
Registered date
| 2025 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066875
