UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Lacrimal Stability Evaluation (Three-Dimensional Image Analysis of Anterior Segment) with Rebamipide Ophthalmic Solution
Title of the study (Brief title)	Lacrimal Stability Evaluation with Rebamipide Ophthalmic Solution
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of influence on tear stability after rebamipide instillation in the Dry Eye patients using AS-OCT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	To evaluate tear stability treated with rebamipide ophthalmic solution
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rebamipide ophthalmic solution 4 times / day, 4weeks
Interventions/Control_2	Control saline eyedrops 4 times / day, 4 weeks
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) Patients who be classified the definition and diagnosis of Dry Eye 2006 and 20 years old or older 2) Patients who be obtained informed consent
Key exclusion criteria	1) Epiphora with suspicion (caused by Allergic conjumctivitis) 2) Meibomian grand dysfunction 3) Atresia puncti lacrimalis (e.g., punctal plug, surgical punctal occlusion) 4) Complication with the upheaval of the keratoconjunctive (e.g., conjunctivochalasis, pterygium) 5) Anatomical and functionl palpebral abnormality (e.g., lid closure imperfection) 6) Instillation of the glaucoma therapeutic drug 7) Patients who cannot be obtained informed consent
Target sample size	30

Research contact person
Name of lead principal investigator	Atsushi Shiraishi
Organization	Ehime University
Division name	Ophthalmology
Address	Shizukawa, Toon, Ehime, Japan
TEL	089-960-5361
Email	shiraia@m.ehime-u.ac.jp

Public contact
Name of contact person	Atsushi Shiraishi
Organization	Ehime University
Division name	Ophthalmology
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5361
Homepage URL
Email	shiraia@m.ehime-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Ehime University
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 10 Month 31 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 28 Day
Last modified on	2017 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019807