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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017620
Receipt No. 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

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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
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 shojig3589eye@athena.ocn.ne.jp

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

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019285

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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