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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009371
Receipt No. R000011017
Scientific Title Study on evaluation of therapeutic efficacy and search for a therapeutic biomarker in dry eye with rebamipide eye drop treatment.
Date of disclosure of the study information 2012/12/01
Last modified on 2016/11/23

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Basic information
Public title Study on evaluation of therapeutic efficacy and search for a therapeutic biomarker in dry eye with rebamipide eye drop treatment.
Acronym Evaluation of therapeutic efficacy and therapeutic biomarker in dry eye with rebamipide eye drop treatment.
Scientific Title Study on evaluation of therapeutic efficacy and search for a therapeutic biomarker in dry eye with rebamipide eye drop treatment.
Scientific Title:Acronym 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
1st name
Middle name
Last name Jun Shoji
Organization Nihon University School of Medicine
Division name Division of Ophthalmology, Department of Visual Sciences
Zip code
Address Oyaguchikamimachi 30-1, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email shojig3589eye@athena.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Shoji
Organization Nihon University School of Medicine
Division name Division of Ophthalmology, Department of Visual Sciences
Zip code
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)

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 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

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
2012 Year 10 Month 02 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000011017

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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