UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044769 |
|---|---|
| Receipt number | R000051138 |
| Scientific Title | Autonomic nervous system in dry eye |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/08/08 12:39:26 |
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Basic information
Public title
Pathology in short BUT dry eye
Acronym
Pathology in short BUT dry eye
Scientific Title
Autonomic nervous system in dry eye
Scientific Title:Acronym
Autonomic nervous system in dry eye
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the characteristics of short BUT dry eye in tear fluid and autonomic nervous activity and examine its association with dry eye symptoms
Basic objectives2
Others
Basic objectives -Others
observation of autonomic nervous activity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
autonomic activity
Key secondary outcomes
dry eye examinations, Idra, OSDI, stress questionnaire, mucin in tears
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Volunteers who understand the research and agree to the research cooperation except for the excluded criteria
Key exclusion criteria
People with diabetes, heart disease, glaucoma instillation, contact lens users
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Kaido |
Organization
Wada eye clinic
Division name
ophthalmology
Zip code
2940045
Address
Houjyo2578-27, Tateyama-shi, Chiba
TEL
0470226311
tomoulton777@ff.em-net.ne.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Kaido |
Organization
Wada eye clinic
Division name
ophthalmology
Zip code
2940045
Address
Houjyo2578-27, Tateyama-shi, Chiba
TEL
0470226311
Homepage URL
tomoulton777@ff.em-net.ne.jp
Sponsor or person
Institute
Wada eye clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ito Clinic
Address
Ooazaminaminakano626-11,Minuma-ku, Saitama City, Saitama
Tel
048-686-5588
arita.reiko@gmail.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
| 2021 | Year | 09 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 15 | Day |
Other
Other related information
(1)Tear function test, (2) Idra, (3) OSDI dry eye questionnaire and stress check questionnaire, (4) measurement of mucin level in tears, (5) evaluation of autonomic nerve activity (Silmee; TDK) are performed, and dry eye and non-dry eye are compared.
Management information
Registered date
| 2021 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051138
