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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011479
Receipt No. 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

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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
Email

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
Email yoko@z7.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013427

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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