UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025466 |
|---|---|
| Receipt number | R000029302 |
| Scientific Title | A study of the intraocular pressure lowering effect of topical application of ripasudil in clinical practice |
| Date of disclosure of the study information | 2017/02/15 |
| Last modified on | 2018/02/27 11:11:28 |
* 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
A study of the intraocular pressure lowering effect of topical application of ripasudil in clinical practice
Acronym
IOP lowering effect of ripasudil in clinical practice
Scientific Title
A study of the intraocular pressure lowering effect of topical application of ripasudil in clinical practice
Scientific Title:Acronym
IOP lowering effect of ripasudil in clinical practice
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ripasudil is a newly developed anti-glaucoma eye drop, which is a Rho kinase inhibitor and reduces intraocular pressure (IOP) by facilitating the conventional outflow of aqueous humor. Clinical trials reported ripasudil monotherapy or a combination of ripasudil with latanoprost or timolol significantly lowered IOP in patients with primary open angle glaucoma (POAG) and ocular hypertension (OH). However, it is not unusual for patients to take at least 2 or more medications to achieve their target IOPs. Nevertheless, there are few reports that evaluated the IOP-lowering effect of ripasudil in patients who already use maximally tolerated numbers of anti-glaucoma medications or in those who had secondary or developmental glaucoma. The purpose of this study is to evaluate the IOP-lowering effect of ripasudil in those who had a variety of types of glaucoma and maximally tolerated number of ant-glaucoma medications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Magnitude and percentage of IOP reduction 6 months after initiation of ripasudil application
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Glaucoma patients, in whom a target IOP was not achieved despite usage of maximally tolerated numbers of anti-glaucoma medications and took ripadusil eyedrops for the first time during December 2014 and November 2015.
Key exclusion criteria
Patients who underwent laser suturelysis intoraocular surgery other than glaucoma surgery by 6 months after the initiation of ripasudil eyedrops.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Nakamura |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Ophthalmology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
manakamu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukako Inoue |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery, Division of Ophthalmology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
Homepage URL
ganka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://clinmedjournals.org/articles/ijocr/international-journal-of-ophthalmology-and-clinical-resea
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
| 2016 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.A.
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029302
