UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046037 |
|---|---|
| Receipt number | R000052547 |
| Scientific Title | Evaluation for topical use of ripasudil as ophthalmic solution. |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2021/11/11 07:56:29 |
* 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
Evaluation for topical use of ripasudil as ophthalmic solution.
Acronym
Evaluation for topical use of ripasudil as ophthalmic solution.
Scientific Title
Evaluation for topical use of ripasudil as ophthalmic solution.
Scientific Title:Acronym
Evaluation for topical use of ripasudil as ophthalmic solution.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for topical use of ripasudil as ophthalmic solution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity, IOP, ECD, CCT, TCT
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Without active ocular surface disease
Key exclusion criteria
With active ocular surface disease
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology
Zip code
701-0192
Address
Matsushima 577, Kurashiki
TEL
0864621111
fujimoto-h@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology
Zip code
701-0192
Address
Matsushima 577, Kurashiki
TEL
0864621111
Homepage URL
fujimoto-h@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Charitable Trust Fund for Ophthalmic Research in Commemoration of Santen Pharmaceutical's Founder 2019
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
Matsushima 577, Kurashiki
Tel
0864621111
fujimoto-h@med.kawasaki-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
https://tvst.arvojournals.org/article.aspx?articleid=2772488
Publication of results
Partially published
Result
URL related to results and publications
https://tvst.arvojournals.org/article.aspx?articleid=2772488
Number of participants that the trial has enrolled
26
Results
The mean endothelial cell density loss 90 to 120 days after surgery, excluding bullous keratopathy patients for whom measurements were not possible was -4.5% in the ripasudil group, which was significantly lower than in control group
Results date posted
| 2021 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Kawasaki Medical School
Management information
Registered date
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2021 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052547
