UMIN-CTR Clinical Trial

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
Email	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
Email	fujimoto-h@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052547