UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013234
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

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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 or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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

Value
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