UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002903 |
|---|---|
| Receipt number | 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 16:42:31 |
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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
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
amanos-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital, Department of Corneal Transplantation
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003519
