UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041093 |
|---|---|
| Receipt number | R000046929 |
| Scientific Title | determination for the effect of reducing the daily variation of intraocular pressure for glaucoma patients, before and after the addition of Ripasudil 0.4% eye drops using the trigger fish system |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2022/01/13 10:06:27 |
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Basic information
Public title
determination for the effect of reducing the daily variation of intraocular pressure for glaucoma patients, before and after the addition of Ripasudil 0.4% eye drops using the trigger fish system
Acronym
determination for the effect of reducing the daily variation of intraocular pressure for glaucoma patients, before and after the addition of Ripasudil 0.4% eye drops using the trigger fish system
Scientific Title
determination for the effect of reducing the daily variation of intraocular pressure for glaucoma patients, before and after the addition of Ripasudil 0.4% eye drops using the trigger fish system
Scientific Title:Acronym
determination for the effect of reducing the daily variation of intraocular pressure for glaucoma patients, before and after the addition of Ripasudil 0.4% eye drops using the trigger fish system
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigated the diurnal variability of intraocular pressure, which is considered to be a risk for the progression of visual field defects in glaucoma patients, whether the addition of ripasudil 0.4% eye drops can be controlled by It will be evaluated using the trigger fish system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the absolute difference between the highest and lowest contactlens sensor values (mVeq), as measured by the trigger fish system before and 2 weeks after the addition of ripasudil 0.4% ophthalmic solution.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Patients with glaucoma suspected of having a diurnal variation in intraocular pressure (IOP) will have a diurnal variation in IOP measured. They will be treated with Ripasudil 0.4% eye drops, and the diurnal variation in IOP will be measured two weeks later.
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) Males and females over 20 years of age at the time of registration.
2) Patients with glaucoma with suspected diurnal variation in intraocular pressure (excluding secondary glaucoma) and patients with suspected glaucoma. A difference of 3 mmHg or more between the intraocular pressure at 9:00 a.m. and 2:00 p.m. is considered intraday IOP Patients with suspected fluctuations.
Key exclusion criteria
1) Patients already on Ripasudil 0.4% eye drops
2) Patients who cannot wear contact lenses (patients with contraindicated target diseases as listed in the Triggerfish package insert)
3) Patients who cannot continue to use Ripasudil 0.4% due to hypersensitivity or other problems to eye drops
4) Other patients who are deemed unsuitable for inclusion in the subject by the physician's judgment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University School of Medicine
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama JAPAN
TEL
045-787-2683
mizunobu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Ishii |
Organization
Yokohama City University School of Medicine
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama JAPAN
TEL
045-787-2683
Homepage URL
mi59333@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
advanced medical research centear
Address
3-9 Fukuura, Kanazawa-ku, Yokohama JAPAN
Tel
045-787-2527
sentan@yokohama-cu.ac.jp
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
| 2020 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046929
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| Registered date | File name |
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