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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046665
Receipt No. 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

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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
Email 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
Email marie.ohgoshi.0408@gmail.com

Sponsor
Institute Fukui Medical University Hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049491

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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