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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013234
Receipt No. R000015442
Scientific Title Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome
Date of disclosure of the study information 2014/04/01
Last modified on 2016/02/10

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Basic information
Public title Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome
Acronym Effect of diquafosol sodium and rebamipide on GVHD and Sjogrens syndrome related dry eye.
Scientific Title Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome
Scientific Title:Acronym Effect of diquafosol sodium and rebamipide on GVHD and Sjogrens syndrome related dry eye.
Region
Japan

Condition
Condition Dry eye related to chronic GVHD and Sjogren s syndrome
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the treatment efficacy of diquafosol sodium and rebamipide on dry eye related chronic GVHD and Sjogrens syndrome
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 test
Tear film breakup time
Fluorescein staining
Rose bengal staining
Subjective symptom
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 Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diquafosol sodium and rebamipide 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1, Newly-diagnosed dry eye patients after hematopoietic stem cell transplantation
2, Dry eye patients with Sjogren's syndrome
3, Dry eye patients according to the criteria of dry eye (2006 Japanese Dry Eye society)
Key exclusion criteria 1, Dry eye syndrome severity level 4 (dry eye workshop classification 2007)
2, Patients dosed diquafosol sodium and / or rebamipide ophthalmic solution
3, Patients having a concern of becoming severe dry eye because of having GVHD in other organs and so on
4, Patients with ocular pemphigoid, and Stevens-Johnson syndrome
5, Patients with a history of ophthalmic surgery within 6 months before the study
6, Patients wearing contact lens
7, Patients who will be applied radiation treatment during the study
8, Patients dosed cevimeline hydrochloride hydrate and /or pilocarpine(eye drop or oral drug)
9, Patients who will be ineligible for registration the study
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 35 Shinanomachi Shinjuku-ku Tokyo, 160-8582, Japan
TEL 0353633972
Email yoko@z7.keio.jp

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 0353633972
Homepage URL
Email yoko@z7.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 04 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
2013 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2018 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
2014 Year 02 Month 24 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015442

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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