UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018340 |
|---|---|
| Receipt number | R000021229 |
| Scientific Title | Effect of GLANATEC ophthalmic solution 0.4% on corneal endothelium |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2016/01/07 13:32:34 |
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Basic information
Public title
Effect of GLANATEC ophthalmic solution 0.4% on corneal endothelium
Acronym
Effect of GLANATEC ophthalmic solution 0.4% on corneal endothelium
Scientific Title
Effect of GLANATEC ophthalmic solution 0.4% on corneal endothelium
Scientific Title:Acronym
Effect of GLANATEC ophthalmic solution 0.4% on corneal endothelium
Region
| Japan |
Condition
Condition
Normal subject
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Glanatec on corneal endothelial morphology in normal subject
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological change
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of GLANATEC ophthalmic solution 0.4% (single dose administration)
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal subject
Key exclusion criteria
Corneal disease
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Okumura |
Organization
Doshisha university
Division name
Department of Biomedical Engineering
Zip code
Address
1-3 Miyakodani Tatara Kyotanabe city, Kyoto, Japan
TEL
0774-65-6508
nokumura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Okumura |
Organization
Doshisha university
Division name
Department of Biomedical Engineering
Zip code
Address
1-3 Miyakodani Tatara Kyotanabe city, Kyoto, Japan
TEL
0774-65-6508
Homepage URL
nokumura@koto.kpu-m.ac.jp
Sponsor or person
Institute
Doshisha university
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, 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 | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26618648
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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
Management information
Registered date
| 2015 | Year | 07 | Month | 17 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021229
