UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026551 |
|---|---|
| Receipt number | R000030490 |
| Scientific Title | Dry Eye Cross-sectional, Multicenter Study in China (DECS-C) |
| Date of disclosure of the study information | 2017/03/14 |
| Last modified on | 2023/10/19 16:48:36 |
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Basic information
Public title
Dry Eye Cross-sectional, Multicenter Study in China (DECS-C)
Acronym
Dry Eye Cross-sectional Study in China (DECS-C)
Scientific Title
Dry Eye Cross-sectional, Multicenter Study in China (DECS-C)
Scientific Title:Acronym
Dry Eye Cross-sectional Study in China (DECS-C)
Region
| Asia(except Japan) |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the status of patients with dry eye who visit medical institutions in China, and to evaluate the proportion of patients diagnosed with dry eye by diagnostic criteria proposed by Asia Dry Eye Society (ADES) among patients diagnosed with dry eye by diagnostic criteria in China and at the same time, to obtain evidence for improvement of the qualities of future dry eye diagnosis and medical care.
Basic objectives2
Others
Basic objectives -Others
To investigate the status of patients with dry eye
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Percent of the subjects who satisfy the ADES dry eye diagnostic criteria
2)Mean values and percent of test/observation results
3)Subject background (including sex, age, history of contact lens wearing, ocular disease and ocular surgeries)
4)Percent of types of dry eye in the Dry Eye Group
5)Correlation in the Dry Eye Group between the scores of questionnaires and test/observation results
6)Correlation in the Dry Eye Group between scores of the dry eye questionnaire score and OSDI scores or DEQS scores
7)Comparison of mucin mRNA expression levels between the Dry Eye Group and the Control Group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dry Eye Group
1)Those aged 18 years or over (regardless of sex)
2)Outpatients
3)Those diagnosed with dry eye based on the dry eye diagnostic criteria in China
Control Group
1)Those aged 18 years or over (regardless of sex)
2)Volunteers without any treatment required ophthalmic diseases
3)At least one eye satisfies the criteria below.
A)Not having dry eye symptoms
B)BUT is more than 5 seconds
C)Unanesthetized Schirmer test is more than 5 millimeters
D)Not having fluorescein staining area
Key exclusion criteria
1)Those who have been diagnosed with dry eye and received the treatment.
2)Those with a history of hypersensitivity to fluorescein
3)Those who the principal investigator and/or subinvestigator consider ineligible for the study
Target sample size
192
Research contact person
Name of lead principal investigator
| 1st name | Liu |
| Middle name | |
| Last name | Zuguo |
Organization
Xiamen University
Division name
Department of ophthalmology
Zip code
361000
Address
No.336 Xiahe Road, Siming District, Xiamen, Fujian
TEL
+86-592-218-3761
zuguoliu@xmu.edu.cn
Public contact
Name of contact person
| 1st name | Huang |
| Middle name | |
| Last name | Caihong |
Organization
Xiamen University
Division name
Department of ophthalmology
Zip code
361000
Address
Xiang'an Campus of Xiamen University, Xiang'an District, Xiamen, Fujian
TEL
+86-592-218-3761
Homepage URL
huangcaihong0327@126.com
Sponsor or person
Institute
Asia Dry Eye Society
Institute
Department
Personal name
Funding Source
Organization
Santen pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Xiamen University
Address
No.422 Siming Nan Road, Siming District, Xiamen, Fujian
Tel
+86-592-2183761
eyeyxllwyh@163.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
| 2017 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://rs.yiigle.com/cmaid/1434969 https://rs.yiigle.com/cmaid/1462356
Number of participants that the trial has enrolled
141
Results
Among the 141 eyes, it was found that 130 eyes had dryness, and 109 eyes had ocular fatigue and 108 eyes had foreign body sensation. Dryness, foreign body sensation, photophobia and poor vision were weakly positively correlated with corneal staining. Pain, photophobia and poor vision were negatively correlated with tear secretion. 75 eyes were with over evaporation dry eye, 43 eyes with mixed dry eye, 18 eyes with aqueous-deficient dry eye and 3 eyes with abnormal tear dynamics dry eyes.
Results date posted
| 2023 | Year | 10 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 22 | Day |
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
The dataset is not publicly available.
IPD sharing Plan description
The dataset is not publicly available.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate dry eye diagnosis and treatment
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030490
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