UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on evaluation of therapeutic efficacy and search for a therapeutic biomarker in dry eye with rebamipide eye drop treatment.
Title of the study (Brief title)	Evaluation of therapeutic efficacy and therapeutic biomarker in dry eye with rebamipide eye drop treatment.
Region	Japan

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

Objectives
Narrative objectives1	Investigation of usefulness of rebamipide eyedrop in dry eye treatment and utility of biomarker in tears to measure the therapeutic effect in dry eye patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of therapeutic effect of dry eye between rebamipide eye drop and hyaluronate sodium eye drop using biomarker in tears.
Key secondary outcomes	Investigation of biomarker in tears that is useful for dry eye practice by comparing patients with dry eye and non-dry eye patients.

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dry eye (+) Rebamipide eye drop (+) Sodium hyaluronate eye drop (-)
Interventions/Control_2	Dry eye (+) Rebamipide eye drop (-) Sodium hyaluronate eye drop (+)
Interventions/Control_3	Dry eye (-) Rebamipide eye drop (-) Sodium hyaluronate eye drop (-)
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	a) Patients with dry eye. 1) Male or female of age of 20 years or older. 2) Patients who provided written informed consent for participating in this study. 3) Patients who are diagnosed as dry eye according to the Japan dry eye diagnostic criteria in 2006. 4) Patients with VAS score of 50 or greater in at least one item in symptom. b) Non-dry eye patients. 1) Male or female of age of 20 years or older. 2) Patients, who are visiting the hospital for existing ocular disease other than anterior segment disease, do not have abnormal findings in anterior segment, and are not receiving treatment with eye drops or contact lens. 3) Patients with VAS score of less than 50 in all items for symptom. 4) Patients who understood the purpose of this study and from whom written consent was obtained.
Key exclusion criteria	a) Patients with dry eye. 1) Patients with anterior segment disease (including blepharitis, lagophthalmos, blepharospasm, iritis and conjunctivochalasis) other than dry eye (History is excluded). 2) Patients who cannot discontinue eye drops (include all eye drops such as prescribed drug and OTC medicine) except for the study drug or the control drug from the study initiation until the end of study treatment or who expect to use those drugs. 3) Patients with punctal plug or patients whose punctal plug fell off within three months prior to the study drug initiation examination. Patients with a history ofsurgical punctual occlusion are also excluded. 4) Patients with a history of surgery of the ocular surface within 12 months, or patients with a history of intraocular surgery within three months prior to the study drug initiation examination. 5) Patients who have difficulty in sampling. 6) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate. b) Non-dry eye patients 1) Patients with anterior segment disease. 2) Patients who used eye drops or the contact lens within two weeks prior to study initiation. 3) Patients with a history of surgery of the ocular surface within 12 months or patients with a history of intraocular surgery within three months prior to the study drug initiation examination. 4) Patients who have difficulty in sampling. 5) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate.
Target sample size	55

Research contact person
Name of lead principal investigator	Jun Shoji
Organization	Nihon University School of Medicine
Division name	Division of Ophthalmology, Department of Visual Sciences
Address	Oyaguchikamimachi 30-1, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	shojig3589eye@athena.ocn.ne.jp

Public contact
Name of contact person	Jun Shoji
Organization	Nihon University School of Medicine
Division name	Division of Ophthalmology, Department of Visual Sciences
Address	Oyaguchikamimachi 30-1, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	shojig@med.nihon-u.ac.jp

Sponsor
Institute	Division of Ophthalmology, Department of Visual Sciences, Nihon University School 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)

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	日本大学医学部付属板橋病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 02 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2015 Year 04 Month 30 Day
Date of closure to data entry	2015 Year 06 Month 01 Day
Date trial data considered complete	2015 Year 07 Month 01 Day
Date analysis concluded	2015 Year 10 Month 01 Day

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

Management information
Registered date	2012 Year 11 Month 20 Day
Last modified on	2016 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011017