UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016230 |
|---|---|
| Receipt number | 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 09:33:20 |
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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
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
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018833
