UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011479 |
|---|---|
| Receipt number | R000013427 |
| Scientific Title | Effect of Tacrolimus on Dry Eye Syndrome Related to Chronic Graft-Versus-Host Disease. |
| Date of disclosure of the study information | 2013/08/24 |
| Last modified on | 2016/08/01 19:25:22 |
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Basic information
Public title
Effect of Tacrolimus on Dry Eye Syndrome Related to Chronic Graft-Versus-Host Disease.
Acronym
Effect of tacrolimus on GVHD related dry eye.
Scientific Title
Effect of Tacrolimus on Dry Eye Syndrome Related to Chronic Graft-Versus-Host Disease.
Scientific Title:Acronym
Effect of tacrolimus on GVHD related dry eye.
Region
| Japan |
Condition
Condition
Dry eye related to chronic GVHD
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment efficacy of tacrolimus on chronic GVHD dry eye
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anterior ocular segment remark
Corneal sensitivity
Schirmer's test
Tear film breakup time
Fluorescein staining
Rose-bengal staining
Subjective symptom
Key secondary outcomes
Cytotechnology(IC, BC)
Biopsy
Non-contact infrared meibography
Laser confocal microscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tacrolimus ophthalmic solution,
vitamin A ophthalmic solution, or/and sodium hyaluronate ophthalmic solution
Interventions/Control_2
Artifical tears, vitamin A ophthalmic solution, or/and sodium hyaluronate ophthalmic solution
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, Newly-diagnosed dry eye patients after hematopoietic stem cell transplantation
2, Dry eye patients according to the criteria of dry eye (2006 Japanese Dry Eye society)
Key exclusion criteria
1, Patients with Sjogren's syndrome, ocular pemphigoid, and Stevens-Johnson syndrome
2, Patients with a history of ophthalmic surgery
3, Patients wearing contact lens
4, Patients who will be applied radiation treatment during the study
5, Patients dosed cevimeline hydrochloride hydrate and /or pilocarpine(eye drop or oral drug)
6, Patients having a concern of becoming severe dry eye because of having GVHD in other organs and so on
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Ogawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku-ku. Tokyo 160-8582
TEL
03-5363-3972
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Ogawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku-ku. Tokyo 160-8582
TEL
03-5363-3972
Homepage URL
yoko@z7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2017 | 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
| 2013 | Year | 08 | Month | 13 | Day |
Last modified on
| 2016 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013427
| 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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