UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040040 |
|---|---|
| Receipt number | R000045651 |
| Scientific Title | Multicenter retrospective study focusing on efficacy and safety of Omidenepag isopropyl |
| Date of disclosure of the study information | 2020/04/15 |
| Last modified on | 2022/04/27 10:17:27 |
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Basic information
Public title
Retrospective study focusing on efficacy and safety of Omidenepag isopropyl
Acronym
Omidenepag isopropyl Retrospective study
Scientific Title
Multicenter retrospective study focusing on efficacy and safety of Omidenepag isopropyl
Scientific Title:Acronym
Multicenter retrospective study of Omidenepag isopropyl
Region
| Japan |
Condition
Condition
Glaucoma or Ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this multicenter retrospective study is to evaluate efficacy and safety of Omidenepag isopropyl in glaucoma or ocular hypertension patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP-lowering effect
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All glaucoma or ocular hypertension patients who were newly treated with Omidenepag isopropyl during observational period
Key exclusion criteria
There is no exclusion criteria in this study.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Hori |
Organization
Santen Pharmaceutical Co. Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9603
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Etsuyo |
| Middle name | |
| Last name | Miyamoto |
Organization
Santen Pharmaceutical Co. Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9603
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinokai Hospital IRB
Address
11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
011-771-1501
info@yurinokai.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 | 15 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12325-022-02069-6
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12325-022-02069-6
Number of participants that the trial has enrolled
827
Results
Refer to paper
Results date posted
| 2022 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
IPD sharing Plan description
The datasets are not publicly available, but are available from the corresponding author on reasonable request.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is retrospective clinical study using existing hospital medical records.
Management information
Registered date
| 2020 | Year | 04 | Month | 03 | Day |
Last modified on
| 2022 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045651
