UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Tacrolimus on Dry Eye Syndrome Related to Chronic Graft-Versus-Host Disease.
Title of the study (Brief title)	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	Yoko Ogawa
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	Shinanomachi 35, Shinjuku-ku. Tokyo 160-8582
TEL	03-5363-3972
Email

Public contact
Name of contact person	Yoko Ogawa
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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