UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the changes of quantity and quality of tears by rebamipide sodium instillation
Acronym	Evaluation of the changes of tears by rebamipide
Scientific Title	Evaluation of the changes of tears by rebamipide
Scientific Title:Acronym	Evaluation of the changes of tears by rebamipide
Region	Japan

Condition
Condition	Dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the changes of quantity and quality of tears by rebamipide instillation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Tear film breakup time, corneal and conjunctival epithelial damage score, tear meniscus radius, Schirmer test(I), spreading velocity of tear film lipid layer, questionnaire(VAS score)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Instillation (rebamipide)
Interventions/Control_2	Instillation (artificial tear)
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	1. Normal subject (20 persons) without following 1)-4) 2. Aqueous tear deficient dry eye patients (20 persons) with following 1)-3). 3. Evaporative dry eye patients (20 persons) with following 2) and 3). 4. Short BUT type dry eye patients (20 persons) with following 2) who have symptoms not responsible for conventional instillation treatment 1) Schirmer test (I) <= 5mm 2) Tear film breakup time <= 5 seconds 3) Positive vital dye staining of cornea and conjunctiva (Fluorescein, Lisamine green) (more than 3, maximum=9)
Key exclusion criteria	Anyone who is considered to be inappropriate for this study (ex. Any allergic history to diquafosol sodium and artificial tear, women who are under pregnant or lactation period)
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Norihiko Middle name Last name Yokoi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	6020841
Address	465 kajiicho kawaramachidori hirokouji noboru kamigyoku Kyoto city
TEL	075-251-5575
Email	nyokoi@koto.kpu-m.ac.jp

Public contact
1st name of contact person	1st name Norihiko Middle name Last name Yokoi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	6020841
Address	465 kajiicho kawaramachidori hirokouji noboru kamigyoku Kyoto city
TEL	075-251-5575
Homepage URL
Email	nyokoi@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	None
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	Faculty of Medicine Research Ethics Committee, Kyoto Prefectural University of Medicine
Address	465 kajiicho hirokoji-agaru kawaramachi-dori kamigyo-ku Kyoto
Tel	075-251-5210
Email	rinri@koto.kpu-m.ac.jp

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	京都府立医科大学病院（京都府）

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 02 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
Oucome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 01 Day
Date of IRB	2012 Year 02 Month 28 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2017 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 03 Month 02 Day
Last modified on	2019 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008754