UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003625 |
|---|---|
| Receipt number | R000004395 |
| Scientific Title | The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step |
| Date of disclosure of the study information | 2010/05/17 |
| Last modified on | 2020/12/10 10:49:05 |
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Basic information
Public title
The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Acronym
The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Scientific Title
The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Scientific Title:Acronym
The effect of Rho kinase inhibitor for the treatment of corneal endothelial dysfunction: the 2nd step
Region
| Japan |
Condition
Condition
Corneal endothelial dysfunction
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 treatment of corneal endothelial dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal endothelial cell density
Key secondary outcomes
Visual acuity
Corneal thickness
Subjective visual function
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Rho kinase inhibitor eye drops (10mM Y-27632) 4 times daily
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
1. Corneal endothelial cell density is lower than 2000cells/mm2 or not detectable by use of non-contact specular microscopy
2. Existence of visual disturbance or an assumption that visual disturbance will occur due to corneal endothelial dysfunction
3. 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
30
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
075-251-5578
nokumura@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
h-hanakura44@mail.pref.kyoto.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）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 17 | 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
20
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
| 2010 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | 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=R000004395
