UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013915 |
|---|---|
| Receipt number | R000015714 |
| Scientific Title | The influence of rebamipide eyedrops towards the glutathione contents of the conjunctival epithelial cells |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2014/05/09 16:24:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The influence of rebamipide eyedrops
towards the glutathione contents of the conjunctival epithelial cells
Acronym
The influence of rebamipide eyedrops
towards the glutathione contents of the conjunctival epithelial cells
Scientific Title
The influence of rebamipide eyedrops
towards the glutathione contents of the conjunctival epithelial cells
Scientific Title:Acronym
The influence of rebamipide eyedrops
towards the glutathione contents of the conjunctival epithelial cells
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of influence and mechanism of rebamipide eyedrops towards the glutathione contents of the conjunctival epithelial cells
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The icGSH contents in conjunctival epithelial cells by MCB staining
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
Healthy volunteers
Dry eye patients
Key exclusion criteria
Contact lens wearers.
People with anterior segment eye diseases except dry eye disease.
Patients with serious systemic diseases.
Patients who use steroid, anti-inflammatory and immune suppression drugs.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Horiuchi |
Organization
Meiji University of Integrative Medicine
Division name
Department of Ophtalmology
Zip code
Address
Hiyoshi, Nantan, Kyoto, 629-0392, Japan
TEL
0771-72-1181
n_horiuchi@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Horiuchi |
Organization
Meiji University of Integrative Medicine
Division name
Department of Ophtalmology
Zip code
Address
Hiyoshi, Nantan, Kyoto, 629-0392, Japan
TEL
0771-72-1181
Homepage URL
n_horiuchi@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji University of Integrative Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
intracellular GSH monitoring is useful for presence of inflammation
Management information
Registered date
| 2014 | Year | 05 | Month | 09 | Day |
Last modified on
| 2014 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015714
