UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029347
Receipt No. 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 2018/04/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Seika Den
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL 047-322-0151
Email dens@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seika Den
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Ophthalmology
Zip code
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL 047-322-0151
Homepage URL
Email dens@tdc.ac.jp

Sponsor
Institute Tokyo Dental College Ichikawa General Hospital
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
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
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033540

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.