UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046665 |
|---|---|
| Receipt number | R000049491 |
| Scientific Title | Assessment of aqueous column dilation with Ripasudil Hydrochloride Hydrate ophthalmic solution(GLANATEC ophthalmic solution 0.4%) |
| Date of disclosure of the study information | 2022/01/18 |
| Last modified on | 2022/03/27 15:48:54 |
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Basic information
Public title
Assessment of vessels in the eye with glaucoma eye drop (Ripasudil Hydrochloride Hydrate ophthalmic solution)
Acronym
Assessment of aqueous column
Scientific Title
Assessment of aqueous column dilation with Ripasudil Hydrochloride Hydrate ophthalmic solution(GLANATEC ophthalmic solution 0.4%)
Scientific Title:Acronym
Assessment of aqueous column
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess of aqueous column dilation with Ripasudil Hydrochloride Hydrate ophthalmic solution(GLANATEC ophthalmic solution 0.4%)
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
width and flow rate of aqueous column
Intraocular pressure at before and after usuing ophthalmic solution
Key secondary outcomes
IOP reduction rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GLANATEC ophthalmic solution
Interventions/Control_2
KISARATAN ophthalmic solution
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
Female
Key inclusion criteria
Healthy students
Key exclusion criteria
Glaucoma
allergic conjunctivitis
Pregnant or nursing mothers
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Suzuki |
Organization
Fukui Medical University Hospital
Division name
Ophthalmology
Zip code
9101193
Address
23-3 Simoaiduki Matsuoka eiheiji-cho Yoshidagun Fukui Prefecture Japan
TEL
0776613111
marie.ohgoshi.0408@gmail.com
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Suzuki |
Organization
Fukui Medical University Hospital
Division name
Ophthalmology
Zip code
9101193
Address
23-3 Simoaiduki Matsuoka eiheiji-cho Yoshidagun Fukui Prefecture Japan
TEL
0776613111
Homepage URL
marie.ohgoshi.0408@gmail.com
Sponsor or person
Institute
Fukui Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Fukui Medical University Hospital
Address
23-3 Simoaiduki Matsuoka eiheiji-cho Yoshidagun Fukui Prefecture Japan
Tel
0776613111
marie.ohgoshi.0408@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
| 2022 | Year | 01 | Month | 18 | 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
| 2021 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049491
| Research Plan | |
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| Registered date | File name |
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