UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018378 |
|---|---|
| Receipt number | R000021281 |
| Scientific Title | A prospective multicenter study of ripasudil effects for secondary glaucoma |
| Date of disclosure of the study information | 2015/07/27 |
| Last modified on | 2020/01/29 21:11:04 |
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Basic information
Public title
A prospective multicenter study of ripasudil effects for secondary glaucoma
Acronym
A prospective multicenter study of ripasudil effects for secondary glaucoma
Scientific Title
A prospective multicenter study of ripasudil effects for secondary glaucoma
Scientific Title:Acronym
A prospective multicenter study of ripasudil effects for secondary glaucoma
Region
| Japan |
Condition
Condition
Secondary glaucoma including exfoliation glauocma, uveitic glaucoma and steroid-induced glaucoma.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intraocular pressure reduction by 0.4% ripasudil (trade name: Glanatec) in case prior anti-glaucoma ophthalmic solution do not respond sufficiently.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of intraocular pressure between at baseleine and at 6-month follow-up period.
Key secondary outcomes
1) Comparison of intraocular pressure (IOP) between at baseleine and at each follow-up period (1-, 2-, 3-, and 6-month).
2) Relationship between IOP reduction and inflammation severelity in uveitic glaucoma patients.
3) Detection of predictive factors for IOP reduction effects.
4) Frequency of adverse events.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.4% ripasudil ophthalmic solution.
twice daily.
for 6 months.
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
Secondary glaucoma patients who need additional IOP reduction therapy will be recruited, when prior anti-glaucoma ophthalmic solution do not respond efficiently.
Key exclusion criteria
1) Contraindicated for use in ripasudil.
2) Patients whose MD value in Humphrey visual field examination (program SITA-standard 24-2) is -12 dB or less.
3) Patient with poor best corrected visual acuity (less than 20/40).
4) Patient with severe refractive error (over +9.0 D or below -9.0 D).
5) Eye with over 3.0 D difference of spherical equivalent power compared to fellow eye.
6) Patients with the corneal disorder to inhibit accurate IOP measurement by Goldmann applanation tonometer.
7) Patients with poor mydriasis and whose optic disc is unobservable.
8) Eyes that had undergone intraocular surgery or intraocular laser therapy. However, the eyes that underwent cataract surgery after a lapse of 6 months could be included.
9) Eyes with a history of ocular trauma.
10) Patients with the retinal disorder which influences visual field.
11) Patients with the optic nerve disorder or intracranial disease which influences visual field.
12) Patients who is rejected as unsuitable case for this study by principal investigator or sub-investigator.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Tanihara |
Organization
Kumamoto University, Faculty of Life Sciences
Division name
Department of Ophthalmology
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
TEL
096-373-5247
tanihara@pearl.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Nakamoto |
Organization
Institute for Clinical Effectiveness
Division name
ROCK-S Study Office
Zip code
860-8556
Address
403 Shimomaruya-cho, Kawara-machi dori Oike kudaru, Nakagyo-ku, Kyoto.
TEL
075-778-5054
Homepage URL
rock@icekyoto.org
Sponsor or person
Institute
Department of Ophthalmology, Faculty of Life Sciences, Kumamoto University.
Institute
Department
Personal name
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
IRB, Faculty of Life Sciences, Kumamoto University.
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.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
熊本大学病院 (熊本県)
岐阜大学病院 (岐阜県)
金沢大学病院 (石川県)
東邦大学病院 (東京都)
広島大学病院 (広島県)
福井大学病院 (福井県)
神戸大学病院 (兵庫県)
東京大学病院 (東京都)
東北大学病院 (宮城県)
秋田大学病院 (秋田県)
新潟大学病院 (新潟県)
北海道大学病院 (北海道)
地域医療機能推進機構 (JCHO) 大阪病院眼科 (大阪府)
宮田眼科病院 (宮崎県)
井上眼科病院 (東京都)
三栄会 ツカザキ病院 眼科 (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 27 | 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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021281
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| Registered date | File name |
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