UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028066 |
|---|---|
| Receipt number | R000032136 |
| Scientific Title | Observational study to investigate the intraocular pressure reduction effect by 0.4% Ripasudil after trabectome |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2019/01/04 18:48:36 |
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Basic information
Public title
Observational study to investigate the intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Acronym
Intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Scientific Title
Observational study to investigate the intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Scientific Title:Acronym
Intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the intraocular pressure reduction effect by 0.4% Ripasudil after trabectome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of intraocular pressure reduction of Ripasudil just before instillation and 2 hours after instillation after trabectome 1 day, 1 week, and 1, 2,3 months
Key secondary outcomes
Effect of intraocular pressure reduction of Ripasudil just before instillation and 2 hours after instillation before trabectome
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Open angle glaucoma patients who are using Ripasudil and satisfy trabectome adaptation criteria during the study period.
2) Patients who have no history of ocular surgery other than cataract surgery.
3) Patients who aged 20 years or older at the time of acquisition.
4) Patient who obtained written consent from the person concerned about participation in this study.
Key exclusion criteria
1) Patients who have history of allergy to Ripasudil.
2) Patients judged inappropriate at the discretion of the research doctor.
3) Patients complicated of clinically serious diseases.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUTA SAITO |
Organization
Showa University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8553
s-yuta@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUTA SAITO |
Organization
Showa University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8553
Homepage URL
s-yuta@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University, School of Medicine, Department of Ophthalmology
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
Address
Tel
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 | 07 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in intraocular pressure before and after Ripasudil instillation after trabectome
Management information
Registered date
| 2017 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032136
