UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017620 |
|---|---|
| Receipt number | R000019285 |
| Scientific Title | Search for the ocular surface biomarker in the Sjogren's syndrome dry eye patients treated with rebamipide ophthalmic solution. |
| Date of disclosure of the study information | 2015/05/20 |
| Last modified on | 2018/11/20 13:09:15 |
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Basic information
Public title
Search for the ocular surface biomarker in the Sjogren's syndrome dry eye patients treated with rebamipide ophthalmic solution.
Acronym
Search for the ocular surface biomarker in dry eye patients treated with rebamipide ophthalmic solution.
Scientific Title
Search for the ocular surface biomarker in the Sjogren's syndrome dry eye patients treated with rebamipide ophthalmic solution.
Scientific Title:Acronym
Search for the ocular surface biomarker in dry eye patients treated with rebamipide ophthalmic solution.
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search for ocular surface biomarker to determine the therapeutic solution in patients with Sjogren syndrome and dry eye.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Serial investigation of the therapeutic effect of rebamipide ophthalmic solution using the ocular surface biomarker in dry eye disease.
Key secondary outcomes
Search of the ocular surface biomarker in the treatment of dry eye disease.
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
3
Purpose of intervention
Treatment
Type of intervention
| Gene |
Interventions/Control_1
SPDEF mRNA expression levels on ocular surface: more than 6.0.
Interventions/Control_2
SPDEF mRNA expression levels on ocular surface: less than 6.0 more than 1.7.
Interventions/Control_3
SPDEF mRNA expression levels on ocular surface: Less than 1.7.
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
Sjogren syndrome dry eye patient
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 Sjogren syndrome dry eye according to both Sjogren syndrome diagnostic criteria and the Japan dry eye diagnostic criteria in 2006.
4) The patient who has either sensation of xerosis or foreign body sensation as main complication, and has 50 points or more of VAS score of the main symptom.
Key exclusion criteria
Sjogren syndrome dry eye patient
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.
4) Patients with a history of surgical punctual occlusion are also excluded.
5) Patients with a history of surgery of the ocular surface within 12 months.
6) Patients with a history of intraocular surgery within three months prior to the study drug initiation examination.
7) Contact lens wearer.
8) Patients with the change of the systemic medicament during study period.
9) Patients who have difficulty in sampling.
10) Patients that a study supervisor or a study partaker judged participation in this study to be inappropriate.
Target sample size
40
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
shojig3589eye@athena.ocn.ne.jp
Sponsor or person
Institute
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 05 | Month | 20 | 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
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 19 | Day |
Last modified on
| 2018 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019285
