UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the intraocular pressure lowering effect of topical application of ripasudil in clinical practice
Title of the study (Brief title)	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	Makoto Nakamura
Organization	Kobe University Graduate School of Medicine
Division name	Department of Surgery, Division of Ophthalmology
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	Yukako Inoue
Organization	Kobe University Graduate School of Medicine
Division name	Department of Surgery, Division of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://clinmedjournals.org/articles/ijocr/international-journal-of-ophthalmology-and-clinical-resea
Results
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