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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010019
Receipt No. 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

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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
Email 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
Email motoko326@gmail.com

Sponsor
Institute Dry Eye Society
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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