UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040222 |
|---|---|
| Receipt number | 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 | 2024/10/30 17:14:27 |
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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 | Teruyo |
| Middle name | |
| Last name | Kida |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Ophthalmology
Zip code
569 8686
Address
2-7, Daigaku-machi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
teruyo.kida@ompu.ac.jp
Public contact
Name of contact person
| 1st name | AKIKAZU |
| Middle name | |
| Last name | SUMINO |
Organization
Osaka Medical and Pharmaceutical University
Division name
Deparment of Ophthalmology
Zip code
569 8686
Address
2-7, Daigaku-machi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
Homepage URL
akikazu121@kcn.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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 and Pharmaceutical University
Address
2-7, Daigaku-machi, Takatsuki, Osaka, Japan
Tel
+81-72-683-1221
roc000@ompu.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
| 2025 | 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
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045733
