UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030325 |
|---|---|
| Receipt number | R000034629 |
| Scientific Title | Development of dry eye self examination |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2017/12/08 21:34:27 |
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Basic information
Public title
Development of dry eye self examination
Acronym
Development of dry eye self examination
Scientific Title
Development of dry eye self examination
Scientific Title:Acronym
Development of dry eye self examination
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure tear secretion with non-invasive method and develop self examination kit for dry eye
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of dry eye self examination
Key secondary outcomes
tear secretion, prevalence of symptoms, severity of signs
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
best corrected visual acuity better than 20/30
Key exclusion criteria
ocular surgery within three months
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | masahiko ayaki |
Organization
keio university
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shijyuku, Tokyo, Japan
TEL
03-3353-1211
ayaki@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masahiko ayaki |
Organization
Keio Univ Sch of Med
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjyuku
TEL
090-2211-8355
Homepage URL
mayaki@olive.ocn.ne.jp
Sponsor or person
Institute
ophthalmology, keio univ
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
matsusaka hospital, tsukuba central hospital,jiyugaoka clinic, komoro hospital, todoroki eye clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
statistical analysis for tear secretion, ocular signs, and symptoms. presentation at some meetings and two papers published.
Management information
Registered date
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2017 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034629
