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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016230
Receipt No. R000018833
Scientific Title The evaluation of safty and efficacy of active-form Vitamin D application on eye lids in normal subjects and patients with meibomian gland dysfunction
Date of disclosure of the study information 2015/01/16
Last modified on 2018/01/18

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Basic information
Public title The evaluation of safty and efficacy of active-form Vitamin D application on eye lids in normal subjects and patients with meibomian gland dysfunction
Acronym The efficacy of active Vitamin D ointment application on the eye lids in meibomian gland dysfunction
Scientific Title The evaluation of safty and efficacy of active-form Vitamin D application on eye lids in normal subjects and patients with meibomian gland dysfunction
Scientific Title:Acronym The efficacy of active Vitamin D ointment application on the eye lids in meibomian gland dysfunction
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 for improvement of meibomian gland function, active-form Vitamin D ointment was applied to the eye lids in normal subjects and meibomian gland dysfunction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes self record, slitlamp microscopy, corneoconjunctival epithelial disorders, tear break-up time, non-contact meibography, meibum condition
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 active-form Vitamin D ointment application twice a day for 2 month, applied to eyelids
Interventions/Control_2 ofloxacin ointment application twice a day for 2 month, applied to eyelids
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
75 years-old >
Gender Male and Female
Key inclusion criteria Subjects who has no past history of allergic reaction of active-form Vitamin D
Subjects with consent for ophthalmic examination
Subjects who is able to visit ophthalmology clinic and to take examinations
Key exclusion criteria past history of allergic reaction of active-form Vitamin D
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiko Arita
Organization Itoh clinic
Division name Ophtalmology
Zip code
Address 626-11, Minaminakano. Minuma-ku, Saitama City
TEL 048-686-5588
Email ritoh@za2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Arita
Organization Itoh Clinic
Division name Ophthalmology
Zip code
Address 626-11, Minaminakano, Minuma-Ku, Saitama City
TEL 048-686-5588
Homepage URL
Email ritoh@za2.so-net.ne.jp

Sponsor
Institute Itoh clinic
Institute
Department

Funding Source
Organization Itoh Clinic
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
2015 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results 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 Completed
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 16 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
2015 Year 01 Month 16 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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