Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058502) titled '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.' on July 17.
Study Type:
Observational
Primary Sponsor:
Institute - Viatris Pharmaceuticals Japan G.K.
Condition:
Condition - Dry eye disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 20000
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066875
Disclaimer: Curated by HT Syndication.
