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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006862
Receipt No. R000008097
Scientific Title Effect of diquafosol sodium on treatment of dry eye associated with chronic graft-versus-host disease
Date of disclosure of the study information 2011/12/13
Last modified on 2016/08/01

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Basic information
Public title Effect of diquafosol sodium on treatment of dry eye associated with chronic graft-versus-host disease
Acronym Effect of diquafosol sodium on graft-vs-host disease related dry eye
Scientific Title Effect of diquafosol sodium on treatment of dry eye associated with chronic graft-versus-host disease
Scientific Title:Acronym Effect of diquafosol sodium on graft-vs-host disease related dry eye
Region
Japan

Condition
Condition To investigate the efficacy and safety of diquafosol ophthalmic solution on cGVHD dry eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of diquafosol ophthalmic solution on cGVHD dry eye
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Symptom
Tear film breakup time
Schirmer test
Fluorescein staining
Rosebengal staining
Corneal sensitivity
Key secondary outcomes Impression cytology
Brush cytology
Biopsy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 diquafosol ophthalmic solution, vitamin a ophthalmic solution, sodium hyaluronate ophthalmic solution
Interventions/Control_2 artifical tears
vitamin a
ophthalmic solution
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 newly diagnosed dry eye patients after hematopoietic stem cell transplantation
dry eye syndrome severity level 1-3 (dry eye workshop classiification 2007)
Key exclusion criteria dry eye syndrome severity level 4 (dry eye workshop classification 2007)
patients having fear of dry eye syndrome progression, such as having graft-vs-host disease in other organs
patients with sjogren's syndrome, ocular cicatricial pemphigoid, or stevens-johnson syndrome
history of ophthalmic surgery
contact lens wearers
patients who will undergo radiotherapy during the testing period
topical or oral administration of cevimeline hydrochloride hemihydrate, pilocarpine
Target sample size 50

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 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 35 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-3972
Homepage URL
Email yoko@z7.keio.jp

Sponsor
Institute Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 慶応義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 13 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
2011 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 17 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
2013 Year 05 Month 01 Day
Date trial data considered complete
2013 Year 07 Month 01 Day
Date analysis concluded
2013 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 08 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=R000008097

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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