UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000030325
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mayaki@olive.ocn.ne.jp

Sponsor
Institute ophthalmology, keio univ
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034629

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.