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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026228
Receipt No. R000030126
Scientific Title One-year Efficacy of Adjunctive Use of Ripasudil, a Rho-Kinase Inhibitor, in Patients with Glaucoma Inadequately Controlled under Maximum Medical Therapy
Date of disclosure of the study information 2017/02/20
Last modified on 2017/02/20

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Basic information
Public title One-year Efficacy of Adjunctive Use of Ripasudil, a Rho-Kinase Inhibitor, in Patients with Glaucoma Inadequately Controlled under Maximum Medical Therapy
Acronym One-year efficacy of Ripasudil
Scientific Title One-year Efficacy of Adjunctive Use of Ripasudil, a Rho-Kinase Inhibitor, in Patients with Glaucoma Inadequately Controlled under Maximum Medical Therapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Inazaki
Organization Department of Ophthalmology and Micro-technology, Yokohama City University School of Medicine, Yokohama, Japan
Division name Ophthalmology
Zip code
Address 4-57 Urafune, Minami,Yokohama,Kanagawa,Japan
TEL 045-261-5656
Email ojionobao@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Inazaki
Organization Department of Ophthalmology and Micro-technology, Yokohama City University School of Medicine, Yokoh
Division name Ophthalmology
Zip code
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)

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 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
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 No longer recruiting
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
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

Other
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

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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