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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030742
Receipt No. R000035103
Scientific Title Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.
Date of disclosure of the study information 2018/01/18
Last modified on 2020/11/04

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Basic information
Public title Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.
Acronym Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.
Scientific Title Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.
Scientific Title:Acronym Efficacy and safety of ripasudil hydrochloride in glaucoma patients being treated by prostaglandin analogues, but their intraocular pressures are 15mmHg or under.
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy and safety of ripasudil hydrochloride in glaucoma patients in case of insufficiently IOP control by prostaglandin-related drug monotherapy although their IOPs are 15mmHg or under.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of intraocular pressure between at baseline (week 0) and at follow-up period (week 12)
Key secondary outcomes 1. Change of intraocular pressure in the study eye at the same time of week 4 from baseline (week 0)
2. Achievement rate of -20% or -30% intraocular pressure reduction in the study eye at the same time of week 12 from baseline (week 0)
3. Difference of intraocular pressure reduction between the study eye and non-treated eye at the same time of week 12 from baseline (week 0)
4. Difference of intraocular pressure reduction between the study eye and non-treated eye at the same time of week 4 from baseline (week 0)
5. Change of indexes listed below at the study eye at the same time of week 12 from baseline (week 0)
6. Change of indexes listed below at the study eye at the same time of week 4 from baseline (week 0)
7. Differences of indexes listed below between the study eye and non-treated eye at the same time of week 12 from baseline (week 0)
8. Differences of indexes listed below between the study eye and non-treated eye at the same time of week 4 from baseline (week 0)
9. Change of difference between the study eye and non-treated eye from baseline to week 12
10. Frequency of adverse events and adverse reactions

<indexes>
intraocular pressure measured by Goldmann applanation tonometer
visual acuity
gonioscopy test
slit lamp microscope test
fundus test
history of prostaglandin-related drug treatment

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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria are included in this study.
1. One prostaglandin-related drug did not provide sufficient reduction in intraocular pressure, and after December 2017, at the discretion of the attending physician, additional glaucoma treatment with ripasudil hydrochloride was required or will be performed Glaucoma patients in the future.
2. Intraocular pressure of both eyes are 15mmHg or lower at their consent and week 0, and difference of intraocular pressure at their consent and at the latest consultation before the consent is 2mmHg or lower.
3. Male and female patients aged 20 years or older and younger than 75 years when giving their consent.
4. Patients who can give their consent in a written form
Key exclusion criteria Patients who fall into any of the following criteria are excluded from participating in the study.
1. Patients with a contraindicated condition to use the study drug
2. Patients who are breastfeeding, pregnant, or parturient
3. Patients whose best-corrected visual acuity is less than 0.5
4. Patients whose spherical equivalent is less than -0.9D or +0.9 or higher
5. Patients in whom the difference of spherical equivalent between both eyes is 3D or higher
6. Patients whose intraocular pressure can not be correctly measured by Goldmann applanation tonometer
7. Patients whose mydriasis is insufficient and in whom the observation of the optic nerve head is impossible
8. Patients with history of invasive eye surgery or laser treatment, except cataract surgery within 6 months
9. Patients with eye trauma
10. Patients with complication of retina disease which affect visual field
11. Patients with optic nerve disease or intracranial disease which affect visual field
12. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiroaki Shirato
Organization Yotsuya Shirato Ophthalmology Clinic
Division name Ophthalmology
Zip code
Address Yotsuya Mitsuke building 3F, 1-1, Yotsuya, Shinjyuku, Tokyo, Japan
TEL 03-3355-4281
Email shirato-eye-clinic@vanilla.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
Address NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL 03-3295-1350
Homepage URL
Email takayama@soiken.com

Sponsor
Institute Yotsuya Shirato Ophthalmology Clinic
Institute
Department

Funding Source
Organization Kowa Company, Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2017 Year 12 Month 21 Day
Date of IRB
2018 Year 10 Month 20 Day
Anticipated trial start date
2019 Year 01 Month 18 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 01 Month 10 Day
Last modified on
2020 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035103

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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