UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009677 |
|---|---|
| Receipt number | R000011350 |
| Scientific Title | Study of anti-inflammatory effect of rebamipide eye drops for ocular surface inflammatory diseases |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2013/01/01 18:29:23 |
* 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
Study of anti-inflammatory effect of rebamipide eye drops for ocular surface inflammatory diseases
Acronym
Study of anti-inflammatory effect of rebamipide eye drops
Scientific Title
Study of anti-inflammatory effect of rebamipide eye drops for ocular surface inflammatory diseases
Scientific Title:Acronym
Study of anti-inflammatory effect of rebamipide eye drops
Region
| Japan |
Condition
Condition
Ocular Surface inflammatory diseases with dry eye (allergic conjuncivitis, vernal conjunctivitis, Stevens-Johnson syndrome, etc)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the anti-inflammatory effect of rebemipide eye drops for ocular surface inflammatory diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
finding about ocular surface inflammation such as conjunctival hyperemia and conjunctival papilla formation, etc.
Key secondary outcomes
tear cytokine etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ocular surface disease patients with dry eye such as allergic conjunctivitis, vernal conjunctivitis, Stevens-Johnson syndrome, etc.
Key exclusion criteria
none
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 kajiicho hirokoujiagaru kawaramachidori kamigyoku kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Ueta |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
mueta@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
rebemipide eye drop 3-4 times per day
Management information
Registered date
| 2013 | Year | 01 | Month | 01 | Day |
Last modified on
| 2013 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011350
