UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	One-year Efficacy of Adjunctive Use of Ripasudil, a Rho-Kinase Inhibitor, in Patients with Glaucoma Inadequately Controlled under Maximum Medical Therapy
Title of the study (Brief title)	One-year efficacy of Ripasudil
Region	Japan

Condition
Condition	Prymary open angle glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the one-year efficacy, ability to lower intraocular pressure, and tolerability of ripasudil, a rho-kinase inhibitor, in patients with glaucoma inadequately controlled with maximum medical therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular pressure lowering effect at 12 months after treatment
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Japanese men or women with primary open angle glaucoma,20 years of age or older, inadequately controlled IOP despite treatment with 3 or 4 drugs, IOP of less than 35 mmHg, and IOP difference less than 2 mm Hg between any 2 eligibility visits. We fixedthe target IOP at 18 mm Hg in the early phase, 15 mmHg in the intermidiate phase, and 12mm Hg in the late phase, according to Anderson's classification. We defined inadequately controlled IOP as a failure to decrease the IOP to its target value under the existing medical therapy.
Key exclusion criteria	The exclusion criteria were as follows: presence of secondary, steroid-related, or traumatic glaucoma, and narrow angles that are defined as grade 2 or less according to the Shaffer classification, as assessed using gonioscopy. We also excluded patients who had undergone ocular surgeries, including cataract surgery within the previous year; retinal laser treatment, selective laser trabeculoplasty, glaucoma surgery, or Nd:YAG laser posterior capsulotomy within the previous 90 days; and eyelid surgery within the previous 120 days. Patients with a corrected visual acuity worse than 20/200 in either eye or with severe visual field defects were also excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroshi Inazaki
Organization	Department of Ophthalmology and Micro-technology, Yokohama City University School of Medicine, Yokohama, Japan
Division name	Ophthalmology
Address	4-57 Urafune, Minami,Yokohama,Kanagawa,Japan
TEL	045-261-5656
Email	ojionobao@yahoo.co.jp

Public contact
Name of contact person	Hiroshi Inazaki
Organization	Department of Ophthalmology and Micro-technology, Yokohama City University School of Medicine, Yokoh
Division name	Ophthalmology
Address	4-57 Urafune, Minami,Yokohama,Kanagawa,Japan
TEL	045-261-5656
Homepage URL
Email	ojionobao@yahoo.co.jp

Sponsor
Institute	Department of Ophthalmology and Micro-technology, Yokohama City University School of Medicine, Yokohama, Japan
Institute
Department

Funding Source
Organization	Department of Ophthalmology and Micro-technology, Yokohama City University School of Medicine, Yokohama, Japan
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 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 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	Partially published
URL releasing results
Results
Other related information	We took the observation of IOP lowering effect and adverse events.

Management information
Registered date	2017 Year 02 Month 20 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030126