UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025159 |
|---|---|
| Receipt number | R000028100 |
| Scientific Title | Efficacy of expression treatment on o-MGD(obstructive meibomian gland dysfunction) |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/09/08 21:39:59 |
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Basic information
Public title
Efficacy of expression treatment on o-MGD(obstructive meibomian gland dysfunction)
Acronym
Efficacy of expression treatment
Scientific Title
Efficacy of expression treatment on o-MGD(obstructive meibomian gland dysfunction)
Scientific Title:Acronym
Efficacy of expression treatment
Region
| Japan |
Condition
Condition
obstructive meibomian gland dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate the effectiveness of expression treatment on o-MGD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Tear break up time (one month after the treatment)
Key secondary outcomes
Corneal and conjunctival staining score, DR-1 grade, Meibum expressibility with Shimazaki classification, Meibography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Non-expressive treatments for one month(thermal therapy, lid hygiene, levofloxacin ophthalmic suspension 1.5% eyedrop qid, Fluorometholone ophthalmic suspension 0.1% tid, hyaluronic acid sodium ophthalmic suspension 0.1% qid, minocycline 200 mg po)
Interventions/Control_2
One month non-expressive treatment and single manual expression
Interventions/Control_3
One month non-expressive treatment and single mechanical expression
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years old meeting the Japanese diagnostic definitions of MGD in 2010 who showed the obstruction of the meibomian glands and signd the informed consent
Key exclusion criteria
Patients who have undergone LASIK or cataract surgery within one year, wear contact lens, have systemic diseases related to dry eyes, use specific medication which may induce dry eye or MGD, have eye disease other than MGD, is pregnant or lactating
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiko Nakayama |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Department of Ophthalmology
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba
TEL
047-322-0151
nnakayama@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiko Nakayama |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Department of Ophthalmology
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba
TEL
047-322-0151
Homepage URL
nnakayama@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College Ichikawa General 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
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
東京歯科大学市川総合病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 06 | Day |
Last modified on
| 2017 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028100
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
