UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study to investigate the intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Title of the study (Brief title)	Intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Region	Japan

Condition
Condition	glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effect of intraocular pressure reduction of Ripasudil just before instillation and 2 hours after instillation after trabectome 1 day, 1 week, and 1, 2,3 months
Key secondary outcomes	Effect of intraocular pressure reduction of Ripasudil just before instillation and 2 hours after instillation before trabectome

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Open angle glaucoma patients who are using Ripasudil and satisfy trabectome adaptation criteria during the study period. 2) Patients who have no history of ocular surgery other than cataract surgery. 3) Patients who aged 20 years or older at the time of acquisition. 4) Patient who obtained written consent from the person concerned about participation in this study.
Key exclusion criteria	1) Patients who have history of allergy to Ripasudil. 2) Patients judged inappropriate at the discretion of the research doctor. 3) Patients complicated of clinically serious diseases.
Target sample size	20

Research contact person
Name of lead principal investigator	YUTA SAITO
Organization	Showa University
Division name	School of Medicine, Department of Ophthalmology
Address	1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL	03-3784-8553
Email	s-yuta@med.showa-u.ac.jp

Public contact
Name of contact person	YUTA SAITO
Organization	Showa University
Division name	School of Medicine, Department of Ophthalmology
Address	1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL	03-3784-8553
Homepage URL
Email	s-yuta@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Showa University, School of Medicine, Department of Ophthalmology
Organization
Division
Category of Funding Organization	Other
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 07 Month 07 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 06 Month 29 Day
Anticipated trial start date	2017 Year 07 Month 07 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Changes in intraocular pressure before and after Ripasudil instillation after trabectome

Management information
Registered date	2017 Year 07 Month 04 Day
Last modified on	2019 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032136