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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002903
Receipt No. R000003519
Scientific Title Study on the effect of caffeine intake on tear production and its correlation with genetic variation
Date of disclosure of the study information 2009/12/24
Last modified on 2012/09/24

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Basic information
Public title Study on the effect of caffeine intake on tear production and its correlation with genetic variation
Acronym Study on the effect of caffeine intake on tear production
Scientific Title Study on the effect of caffeine intake on tear production and its correlation with genetic variation
Scientific Title:Acronym Study on the effect of caffeine intake on tear production
Region
Japan

Condition
Condition Dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the effect of caffeine intake on tear production and its correlation with genetic variations.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tear meniscus height
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Caffeine (Washout) Placebo
Interventions/Control_2 Placebo (Washout) Caffeine
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Normal adults
Key exclusion criteria Patients with dry eye of moderate degree or more.
Schirmer test value of 5 mm or less.
Tear breakup time of 5 seconds or less.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Amano
Organization University of Tokyo Hospital
Division name Department of Corneal Transplantation
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-5109
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shiro Amano
Organization University of Tokyo Hospital
Division name Department of Corneal Transplantation
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5800-5109
Homepage URL
Email amanos-tky@umin.ac.jp

Sponsor
Institute University of Tokyo Hospital, Department of Corneal Transplantation
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
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 東京大学医学部附属病院(東京都)、前田眼科医院(福島県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Arita R, Yanagi Y, Honda N, Maeda S, Maeda K, Kuchiba A, Yamaguchi T,  Yanagihara Y, Suzuki H, Amano S. Caffeine increases tear volume depending on polymorphisms within the adenosine A2a receptor gene and cytochrome P450 1A2. Ophthalmology119:972-978, 2012
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
2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 12 Month 15 Day
Last modified on
2012 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003519

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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