UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017305 |
|---|---|
| Receipt number | R000019807 |
| Scientific Title | Lacrimal Stability Evaluation (Three-Dimensional Image Analysis of Anterior Segment) with Rebamipide Ophthalmic Solution |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2017/10/29 11:03:23 |
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Basic information
Public title
Lacrimal Stability Evaluation (Three-Dimensional Image Analysis of Anterior Segment) with Rebamipide Ophthalmic Solution
Acronym
Lacrimal Stability Evaluation with Rebamipide Ophthalmic Solution
Scientific Title
Lacrimal Stability Evaluation (Three-Dimensional Image Analysis of Anterior Segment) with Rebamipide Ophthalmic Solution
Scientific Title:Acronym
Lacrimal Stability Evaluation with Rebamipide Ophthalmic Solution
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of influence on tear stability after rebamipide instillation in the Dry Eye patients using AS-OCT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
To evaluate tear stability treated with rebamipide ophthalmic solution
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rebamipide ophthalmic solution
4 times / day, 4weeks
Interventions/Control_2
Control saline eyedrops
4 times / day, 4 weeks
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
1) Patients who be classified the definition and diagnosis of Dry Eye 2006 and 20 years old or older
2) Patients who be obtained informed consent
Key exclusion criteria
1) Epiphora with suspicion (caused by Allergic conjumctivitis)
2) Meibomian grand dysfunction
3) Atresia puncti lacrimalis (e.g., punctal plug, surgical punctal occlusion)
4) Complication with the upheaval of the keratoconjunctive (e.g., conjunctivochalasis, pterygium)
5) Anatomical and functionl palpebral abnormality (e.g., lid closure imperfection)
6) Instillation of the glaucoma therapeutic drug
7) Patients who cannot be obtained informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Shiraishi |
Organization
Ehime University
Division name
Ophthalmology
Zip code
Address
Shizukawa, Toon, Ehime, Japan
TEL
089-960-5361
shiraia@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Shiraishi |
Organization
Ehime University
Division name
Ophthalmology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5361
Homepage URL
shiraia@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Ehime University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 05 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 28 | Day |
Last modified on
| 2017 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019807
