UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006862 |
|---|---|
| Receipt number | 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 19:23:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yoko@z7.keio.jp
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008097
