UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009371 |
|---|---|
| Receipt number | 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 09:44:43 |
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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
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
shojig@med.nihon-u.ac.jp
Sponsor or person
Institute
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011017
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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