UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013458 |
|---|---|
| Receipt number | R000015715 |
| Scientific Title | The research of punctal plug migration into lacrimal passage |
| Date of disclosure of the study information | 2014/03/20 |
| Last modified on | 2021/09/22 11:37:37 |
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Basic information
Public title
The research of punctal plug migration into lacrimal passage
Acronym
The research of punctal plug migration into lacrimal passage
Scientific Title
The research of punctal plug migration into lacrimal passage
Scientific Title:Acronym
The research of punctal plug migration into lacrimal passage
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate what the punctal plug migration into lacrimal passage is like after the insertion of it.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of occurring punctal plug migration into lacrimal passage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
lacrimal endoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who lost the punctal plug after insertion of it
Key exclusion criteria
Patients who reject to check the lacrimal passage by lacrimal endoscopy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Imamura |
Organization
Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
671-1227
Address
68-1, Waku, Aboshi-ku, Himeji-city
TEL
079-272-8555
h.imamura@tsukazaki-eye.net
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Hitoshi Imamura |
Organization
Tsukazaki Hospital
Division name
Department of Ophthalmology
Zip code
671-1227
Address
68-1, Waku, Aboshi-ku, Himeji-city
TEL
079-272-8555
Homepage URL
h.imamura@tsukazaki-eye.net
Sponsor or person
Institute
Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsukazaki Hospital
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
Tsukazaki Hospital
Address
68-1, Waku, Aboshi-ku, Himeji-city
Tel
0792-98-8555
h.imamura@tsukazaki-eye.net
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
ツカザキ病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015715
