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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025466
Receipt No. 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

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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
Email 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
Email ganka@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029302

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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