UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033802 |
|---|---|
| Receipt number | R000038179 |
| Scientific Title | Evaluation of dry eye in athletes |
| Date of disclosure of the study information | 2018/08/19 |
| Last modified on | 2023/11/27 22:06:01 |
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Basic information
Public title
Evaluation of dry eye in athletes
Acronym
Dry eye in athletes
Scientific Title
Evaluation of dry eye in athletes
Scientific Title:Acronym
Dry eye in athletes
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate dry eye condition of the athlete of various sports. We investigate the prevalence of dry eye for each sport and the difference by each sport. To investigate the effects of eye drop on dry eye athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjective symptoms score by the dry eye related quality of life score (DEQS) every week
Key secondary outcomes
Visual Acuity
Intraocular pressure
Tear break-up time
Maximum blink inteval
Corneal fluorescein staining (CFS) score
Shirmer 1 test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eye drop group
Interventions/Control_2
non-eye drop group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)The individual athlete has signed a written consent form in regards to participation in this research.
(2)Participants are over 20 years old at the time of the obtained written consent.
Key exclusion criteria
Persons who are diagnosed to be inappropriate for this research by the physician in charge of implementing this research.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University Faculty of medicine
Division name
Ophthalmology
Zip code
1113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
tinoma@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University Faculty of medicine
Division name
Ophthalmology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
tinoma@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Research and Trial Center
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.ac.jp
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 | 08 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 19 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038179
