UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024795 |
|---|---|
| Receipt number | R000028527 |
| Scientific Title | The effect of the association with dry eye syndrome and the periocular drying. |
| Date of disclosure of the study information | 2016/11/13 |
| Last modified on | 2017/10/31 10:39:08 |
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Basic information
Public title
The effect of the association with dry eye syndrome and the periocular drying.
Acronym
Lines study
Scientific Title
The effect of the association with dry eye syndrome and the periocular drying.
Scientific Title:Acronym
Lines study
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With an examination related to dry eye diagnosis and measuring the oil content and moisture of the skin around the eyes, the goal is to confirm the relationship between dry eye and dryness around the eyes.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of index and index about the dry skin about the dry eye syndrome.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1)Patients with dry eye.
2)Patients who is between 20 and 60 years old.
3)Patients who provided written informed consent for participating in this study.
4)patients who is testable by the instructions such as researchers on an agreement acquisition day.
5)Male and Female
6)The contact lens use or nonuse doesn't matter.
Key exclusion criteria
1)Patients with the past of may have an influence on cornea and the tear, treating it surgically.
2)Skin treatment, patients ( include eye ointment, use of eye cream) who cares around the eyelid and the eyelid.
3)Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate.
4)Patients whom a study person in charge judged to be inappropriate to carry out this study safely
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Suzuki |
Organization
Ishizuchi Eye Clnic
Division name
Director
Zip code
Address
1-8-30 Shonaicyo Niihama-city Ehime
TEL
0898-33-3069
t-suzuki@ishizuchi-eye-clinic.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Suzuki |
Organization
Ishizuchi Eye Clnic
Division name
Director
Zip code
Address
1-8-30 Shonaicyo Niihama-city Ehime
TEL
0898-33-3069
Homepage URL
t-suzuki@ishizuchi-eye-clinic.jp
Sponsor or person
Institute
Ishizuchi Eye Clnic
Institute
Department
Personal name
Funding Source
Organization
Menicon 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
| 2016 | Year | 11 | Month | 13 | 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
| 2016 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 11 | Month | 11 | Day |
Last modified on
| 2017 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028527
