UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010019 |
|---|---|
| Receipt number | R000011728 |
| Scientific Title | Intervention Study on Dry Eye among office workers |
| Date of disclosure of the study information | 2013/02/12 |
| Last modified on | 2014/08/12 09:04:04 |
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Basic information
Public title
Intervention Study on Dry Eye among office workers
Acronym
Intervention Study on Dry Eye among office workers
Scientific Title
Intervention Study on Dry Eye among office workers
Scientific Title:Acronym
Intervention Study on Dry Eye among office workers
Region
| Japan |
Condition
Condition
Dry Eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To conduct a therapeutic exploratory investigation to determine the parameter changes in subjective and objective symptoms by lifestyle interventional therapy in office workers with definite and probable dry eye.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Dry eye symptoms
tear breakup time
Schirmer test value
cornea staining score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
life style intervention
Interventions/Control_2
Control
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Definitive Dry Eye
Probable Dry Eye
Key exclusion criteria
People engaging in regular vigorous exercise or being on diet
People under dry eye treatment including eyedrops and punctual plug
Pregnant or lactating women
Patients with either cataract or glaucoma
Patients with serious cardiovascular, hepatic, or renal diseases
Patients with malignant tumors
Patients who participated in any clinical study within three month prior to signing the informed consent
People whom the investigator or the subinvestigators consider to be ineligible for the intervention therapy judging from their medical history or general condition
People whom the investigator or the subinvestigators consider to be ineligible for the intervention therapy in any other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsubota |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
0353633866
tsubota@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Kawashima |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
motoko326@gmail.com
TEL
0353633866
Homepage URL
motoko326@gmail.com
Sponsor or person
Institute
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
Other related organizations
Co-sponsor
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
| 2013 | Year | 02 | Month | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 12 | Day |
Last modified on
| 2014 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011728
