UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050123 |
|---|---|
| Receipt number | R000057092 |
| Scientific Title | Ripasudil-brimonidine fixed-dose combination Observational study to Confirm the safety and efficacy of rho Kinase inhibitor and alpha2 adrenergic receptor agonist for long-term use in Japanese patients with glaucoma |
| Date of disclosure of the study information | 2023/01/24 |
| Last modified on | 2024/03/26 18:43:09 |
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Basic information
Public title
Ripasudil-brimonidine fixed-dose combination Observational study to Confirm the safety and efficacy of rho Kinase inhibitor and alpha2 adrenergic receptor agonist for long-term use in Japanese patients with glaucoma
Acronym
ROCK-alpha study
Scientific Title
Ripasudil-brimonidine fixed-dose combination Observational study to Confirm the safety and efficacy of rho Kinase inhibitor and alpha2 adrenergic receptor agonist for long-term use in Japanese patients with glaucoma
Scientific Title:Acronym
ROCK-alpha study
Region
| Japan |
Condition
Condition
glaucoma, ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of ripasudil-brimonidine fixed-dose combination in general clinical practice environment by long-term (2 years) observation in patients with glaucoma or ocular hypertension who are newly prescribed the ripasudil-brimonidine fixed-dose combination.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of side effect by the study agent within 24 months
Key secondary outcomes
1. Safety evaluation endpoints
1) Presence or absence of side effect by the study agent within 3 months
2) Frequency of adverse event or side effect stratified by previous use of ripasudil or brimonidine
3) Ophthalmic adverse event or side effect related to allergy or inflammation
- Frequency
- Cumulative incidence of first occurrence
- Cumulative incidence of first occurrence which causes the discontinuation of the study
- Analysis of risk factors
2. Efficacy evaluation endpoints
1) Change and percent change of intraocular pressure from baseline to each observation point
2) Change and percent change of intraocular pressure from baseline to each observation point stratified by disease type, patients characteristics, concomitant agents, and number of concomitant agents
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with glaucoma or ocular hypertension
2. Patients who started to use ripasudil-brimonidine fixed-dose combination in general clinical practice, and who give their consent to participate in this study within 8 weeks after the start of prescription of it
3. Patients whose intraocular pressure was measured before the the start of prescription of the ripasudil-brimonidine fixed-dose combination
Key exclusion criteria
1. Patients who had used the ripasudil-brimonidine fixed-dose combination and had discontinued the use of it
2. Patients with a history of hypersensitivity to ripasudil or brimonidine
3. low birth weight infant, newborn infant, infant, or toddler who is younger than 2 years
4. Patients who need regal representatives to give their consent
5. Patients with other conditions that the investigators judge to be inappropriate for the study
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Tanihara |
Organization
Biei Municipal Hospital
Kumamoto University
Division name
Ophthalmology
Zip code
071-0207
Address
3-8-35, Naka-machi, Biei Town, Kamikawa-gun, Hokkaido
TEL
0166-68-7111
tanihara@pearl.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Tomita |
Organization
EviPRO Co., Ltd.
Division name
Clinical Study Support Division
Zip code
101-0032
Address
KDX Iwamoto-cho Building 2F, Iwamoto-cho 3-11-9, Chiyoda, Tokyo, 101-0032, Japan
TEL
03-5829-4110
Homepage URL
http://japanpro.jp/rock-a/index.html
tomita_yasunori@evipro.co.jp
Sponsor or person
Institute
Japan society for Patient Reported Outcome
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 of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
| 2023 | Year | 01 | Month | 24 | 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
| 2022 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
2-year observation is conducted in general practice enviroment in patients with glaucoma or ocular hypertension, who newly started to use ripasudil-brimonidine combination ophthalmic solution
Management information
Registered date
| 2023 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057092
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| Registered date | File name |
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| Registered date | File name |
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