UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007082 |
|---|---|
| Receipt number | R000008342 |
| Scientific Title | The effect of Rho kinase inhibitor for the prevention of post-keratoplasty corneal endothelial cell loss |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2020/12/10 10:52:35 |
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Basic information
Public title
The effect of Rho kinase inhibitor for the prevention of post-keratoplasty corneal endothelial cell loss
Acronym
The effect of Rho kinase inhibitor for the prevention of post-keratoplasty corneal endothelial cell loss
Scientific Title
The effect of Rho kinase inhibitor for the prevention of post-keratoplasty corneal endothelial cell loss
Scientific Title:Acronym
The effect of Rho kinase inhibitor for the prevention of post-keratoplasty corneal endothelial cell loss
Region
| Japan |
Condition
Condition
Post-keratoplasty corneal endothelial cell loss
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of using Rho kinase inhibitor eye drops for the prevention of post-keratoplasty corneal endothelial cell loss
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal endothelial cell density
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Administration of Rho kinase inhibitor eye drops
Interventions/Control_2
Administration of vehicle
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. Post keratoplasty
2. Obtainment of prior written informed consent
Key exclusion criteria
1. Pregnant or breast-feeding women
2. Patients with a psychological disorder or who could not comprehend instructions from the physician
3. Other criteria deemed improper for inclusion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
465 Hirokoji Kawaramachi Kamigyo-ku Kyoto, Japan 602-8566
TEL
075-221-2621
shigeruk@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Okumura |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
465 Hirokoji Kawaramachi Kamigyo-ku Kyoto, Japan 602-8566
TEL
075-251-5578
Homepage URL
nokumura@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine IRB
Address
465 Kajii-cho Kamigyou-ku Kyoto
Tel
075-251-5210
rinri@koto.kpu-m.ac.jp
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
京都府立医科大学附属病院（京都府）、バプテスト眼科クリニック（京都府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
10
Results
NA
Results date posted
| 2020 | Year | 12 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008342
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
