UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026228
Receipt number 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 16:55:49

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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