UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	effect of rebamipide on dry eye syndrome related to chronic graft versus host disease a randomized parallel group trial
Title of the study (Brief title)	effect of rebamipide on gvhd related dry eye
Region	Japan

Condition
Condition	To investigate the treatment efficacy of rebamipide on chronic GVHD dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the treatment efficacy of rebamipide 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 schrmer test tear film breakup time fluorescein staining lisamine green staining subjective symptom oxidative stress marker in tear film
Key secondary outcomes

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	Rebamipide ophthalmic suspension, vitamin A ophthalmic solution, or/and sodium hyaluronate ophthalmic solution
Interventions/Control_2	Artificial 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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1 newly diagnosed dry eye patients after hematopoietic stem cell transplantation 2 dry eye severity level 1 2 3 dews 2007
Key exclusion criteria	1 dry eye severity level 4 dews 2007 2 patients having a concern of becoming severe dry eye because of having gvhd in other organs and so on 3 patients with sjogrens syndrome, ocular pemphigoid, and Stevenes-Johnson symdrome 4 patients with a history of ophthalmic surgery 5 patients wearing contact lens 6 patients who will be applied radiation treatment during the study 7 patients dosed cevimeline hydrochloride hydrate and or pilocarpine eye drop or oral drug
Target sample size	100

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	yoko@z7.keio.jp

Public contact
Name of contact person	Yoko Ogawa
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35 Shinanomachi Shinjukuku Tokyo, Japan
TEL	03-5363-3972
Homepage URL
Email	yoko@z7.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 09 Day
Last follow-up date
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 04 Month 05 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=R000012199