UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029347 |
|---|---|
| Receipt number | R000033540 |
| Scientific Title | Safety and efficacy of the treatment of active-form Vitamin D application for meibomian gland dysfunction |
| Date of disclosure of the study information | 2017/09/29 |
| Last modified on | 2021/04/05 10:55:25 |
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Basic information
Public title
Safety and efficacy of the treatment of active-form Vitamin D application for meibomian gland dysfunction
Acronym
Treatment of active-form Vitamin D application for MGD
Scientific Title
Safety and efficacy of the treatment of active-form Vitamin D application for meibomian gland dysfunction
Scientific Title:Acronym
Treatment of active-form Vitamin D application for MGD
Region
| Japan |
Condition
Condition
meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of active-form Vitamin D application for meibomian gland dysfunction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective symptom, slitlamp microscopy, tear function, non-contact meibography
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
active-form Vitamin D ointment application on the eye lids twice a day for 3 months
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects diagnosed by the definition of MGD.
Subjects having primary MGD or secondary MGD due to Stevens-Johnson syndrome, Ocular cicatricial pemphigoid, GVHD, and post-chemical or thermal bun.
Key exclusion criteria
Allergic reaction of active-form Vitamin D3
Subjects who have any ocular surface disease other than MGD
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seika |
| Middle name | |
| Last name | Den |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Department of Ophthalmology
Zip code
2728513
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
dens@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Seika |
| Middle name | |
| Last name | Den |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Department of Ophthalmology
Zip code
2728513
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
Homepage URL
dens@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Dental College
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
Tel
047-322-0151
dens@tdc.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
| 2017 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033540
