UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027065 |
|---|---|
| Receipt number | R000031024 |
| Scientific Title | Effects of intraocular pressure reduction in combined use with ripasudil and brimonidine, or pilocarpine in healthy adult volunteers. |
| Date of disclosure of the study information | 2017/04/20 |
| Last modified on | 2018/04/01 19:30:40 |
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Basic information
Public title
Effects of intraocular pressure reduction in combined use with ripasudil and brimonidine, or pilocarpine in healthy adult volunteers.
Acronym
Effects of IOP reduction in combined use with ripasudil and brimonidine, or pilocarpine.
Scientific Title
Effects of intraocular pressure reduction in combined use with ripasudil and brimonidine, or pilocarpine in healthy adult volunteers.
Scientific Title:Acronym
Effects of IOP reduction in combined use with ripasudil and brimonidine, or pilocarpine.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of intraocular pressure reduction in combined use with ripasudil and brimonidine, or pilocarpine in healthy adult volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP reduction
Key secondary outcomes
Pupil diameter
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ripasudil and brimonidine, or pilocarpine
(one drop instillation)
Interventions/Control_2
brimonidine
(one drop instillation)
Interventions/Control_3
ripasudil and brimonidine
(one drop instillation)
Interventions/Control_4
pilocarpine
(one drop instillation)
Interventions/Control_5
ripasudil and pilocarpine
(one drop instillation)
Interventions/Control_6
no treatment
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
A person without ocular diseases.
Key exclusion criteria
Persons who are contraindicated for the test drugs.
Persons who are allergic to ripasudil.
Person who use contact lenses.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Miyata |
Organization
Miyata Eye Hospital
Division name
ophthalmology
Zip code
Address
6-3 Kurahara, Miyakonojyo, Miyazaki, 885-0051, Japan
TEL
0986-22-1441
miyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TakashI Ono |
Organization
Miyata Eye Hospital
Division name
ophthalmology
Zip code
Address
6-3 Kurahara, Miyakonojyo, Miyazaki, 885-0051, Japan
TEL
0986-22-1441
Homepage URL
ono@miyata-med.ne.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031024
