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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040222
Receipt No. R000045733
Scientific Title Effect of Omidenepag Eye Drop on Optic Nerve Head Microcirculation, Shape of Optic Disc and Visual Field.
Date of disclosure of the study information 2020/04/23
Last modified on 2020/04/23

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Basic information
Public title Effect of Omidenepag Eye Drop on Optic Nerve Head Microcirculation, Shape of Optic Disc and Visual Field.

Acronym Omidenepag Eye Drop and Optic Nerve Head Microcirculation, Shape of Optic Disc and Visual Field.
Scientific Title Effect of Omidenepag Eye Drop on Optic Nerve Head Microcirculation, Shape of Optic Disc and Visual Field.
Scientific Title:Acronym Omidenepag Eye Drop and Optic Nerve Head Microcirculation, Shape of Optic Disc and Visual Field.
Region
Japan

Condition
Condition Primary Open Angle Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Evaluate the Effect of Omidenepag, EP2 Receptor Agonist, on Optic Nerve Head Microcirculation and Shape of Optic Disc and Visual Field.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Optic Nerve Head Microcirculation (Before and 3, 6, 12 Month after administration )
Key secondary outcomes Intraocular Pressure, Blood Pressure, Pulse Rate, Shape of Optic, Disc, Humphrey Visual Field (Before and 3, 6, 12 Month after administration )

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Omidenepag Administration for 3 Moths and Latanoprost for 12 moths
Interventions/Control_2 Latanoprost for 3 Moths and Omidenepag Administration for 12 moths
Interventions/Control_3 Omidenepag Administration for 12 moths
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patient with Primary Open Angle Glaucoma Including Normal Tension Glaucoma and Laser Speckle Flowgraphy, Optical Coherence Tomography Angiography and Visual Field are measurable.
Key exclusion criteria Patient with Ocular Eye Disease Except for Glaucoma, High Myopia ( more than 6D ), Systemic Diseases which Treatment influences Ocular Blood Flow, Ocular Opacity witch interrupt Ocular Funds Observation, Allergy to Omidenepag
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tsunehiko
Middle name
Last name Ikeda
Organization Osaka Medical College
Division name Department of Ophthalmology
Zip code 569 8686
Address 2-7, Daigaku-machi, Takatsuki, Osaka, Japan
TEL +81-72-683-1221
Email tikeda@osaka-med.ac.jp

Public contact
Name of contact person
1st name SHOTA
Middle name
Last name KOJIMA
Organization Osaka Medical Collge
Division name Deparment of Ophthalmology
Zip code 569 8686
Address 2-7, Daigaku-machi, Takatsuki, Osaka, Japan
TEL +81-72-683-1221
Homepage URL
Email shota@osaka-med.ac.jp

Sponsor
Institute Osaka Medical Collge
Institute
Department

Funding Source
Organization Osaka Medical Collge
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 Osaka Medical Collge
Address 2-7, Daigaku-machi, Takatsuki, Osaka, Japan
Tel +81-72-683-1221
Email roc000@osaka-med.ac.jp

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
2020 Year 04 Month 23 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
2020 Year 02 Month 05 Day
Date of IRB
2020 Year 02 Month 05 Day
Anticipated trial start date
2020 Year 02 Month 05 Day
Last follow-up date
2022 Year 12 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 23 Day
Last modified on
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045733

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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