Unique ID issued by UMIN | UMIN000013234 |
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Receipt number | 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 11:31:11 |
Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome
Effect of diquafosol sodium and rebamipide on GVHD and Sjogrens syndrome related dry eye.
Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome
Effect of diquafosol sodium and rebamipide on GVHD and Sjogrens syndrome related dry eye.
Japan |
Dry eye related to chronic GVHD and Sjogren s syndrome
Ophthalmology |
Others
NO
To investigate the treatment efficacy of diquafosol sodium and rebamipide on dry eye related chronic GVHD and Sjogrens syndrome
Efficacy
Exploratory
Pragmatic
Not applicable
Anterior ocular segment remark
Corneal sensitivity
Schirmer test
Tear film breakup time
Fluorescein staining
Rose bengal staining
Subjective symptom
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Pseudo-randomization
2
Treatment
Medicine |
Diquafosol sodium and rebamipide ophthalmic solution
Artifical tears, vitamin A ophthalmic solution, or/and sodium hyaluronate ophthalmic solution
20 | years-old | <= |
75 | years-old | > |
Male and Female
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)
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
20
1st name | |
Middle name | |
Last name | Yoko Ogawa |
Keio University School of Medicine
Department of ophthalmology
35 Shinanomachi Shinjuku-ku Tokyo, 160-8582, Japan
0353633972
yoko@z7.keio.jp
1st name | |
Middle name | |
Last name | Yoko Ogawa |
Keio University School of Medicine
Department of Ophthalmology
Shinanomachi 35, Shinjuku-ku. Tokyo 160-8582
0353633972
yoko@z7.keio.jp
Keio University School of Medicine
Keio University
Self funding
Japan
None
NO
慶應義塾大学病院(東京都)
2014 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 12 | Month | 20 | Day |
2014 | Year | 04 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2014 | Year | 02 | Month | 24 | Day |
2016 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015442
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