UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045019 |
|---|---|
| Receipt number | R000051423 |
| Scientific Title | Effect of ophthalmic solution on autonomic nerve system |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/01/13 10:26:00 |
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Basic information
Public title
Effect of ophthalmic solution on autonomic nerve system
Acronym
Effect of ophthalmic solution on autonomic nerve system
Scientific Title
Effect of ophthalmic solution on autonomic nerve system
Scientific Title:Acronym
Effect of ophthalmic solution on autonomic nerve system
Region
| Japan |
Condition
Condition
normal eyes
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ophthalmic solution on the autonomic nerves
Basic objectives2
Others
Basic objectives -Others
Tear stability, comfort and temperature sensation for ophthalmic solution
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in LH / FH
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
normal subjects without corneal damage
Key exclusion criteria
subjects with corneal damage
diabetes mellitus
heart diseases
collagen disease
subjects with diseases that affect the nervous system
Target sample size
20
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
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ito Clinic
Address
ooaza minaminakano 626-11, minuma-ku, saitama-shi, saitama-ken
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
40
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
Completed
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 | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will compare the effects of instillation and instillation movement on the autonomic nerves.
Management information
Registered date
| 2021 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051423
