UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055230 |
|---|---|
| Receipt number | R000063101 |
| Scientific Title | Database study on the Prescription status of glaucoma medications |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2026/01/07 14:55:46 |
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Basic information
Public title
Database study on the Prescription status of glaucoma medications
Acronym
Database study on the Prescription status of glaucoma medications
Scientific Title
Database study on the Prescription status of glaucoma medications
Scientific Title:Acronym
Database study on the Prescription status of glaucoma medications
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the actual prescription status of first-line drugs for the treatment of glaucoma using the JMDC Claims database.
Basic objectives2
Others
Basic objectives -Others
treatment persistence rate
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Treatment persistence rates of omidenepag isopropyl ophthalmic solution monotherapy group and FP agonist monotherapy group
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with glaucoma during the enrollment period
Patients who were diagnosed with glaucoma and started a prescription of omidenepag isopropyl ophthalmic solution, FP agonists, or beta-blockers during the enrollment period
Patients 18 years of age or older on the index date
Key exclusion criteria
Patients who were concomitantly prescribed glaucoma ophthalmic solutions other than the target medication on the index date
Patients with a baseline period of less than 6 months
Patients who were prescribed the same active pharmaceutical ingredient as the target drug during the baseline period
Patients who underwent glaucoma surgery during the baseline period
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Miyahara |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.com
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Otsuka |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
Homepage URL
clinical@santen.com
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
Kyoyukai RiverSide Clinic Institutional Review Board
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.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
| 2024 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-025-22758-w?utm_source=rct_ congratemailt&utm_medium=email&ut
Number of participants that the trial has enrolled
36450
Results
Refer to paper
Results date posted
| 2026 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 06 | Day |
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the JMDC Claims database.
Management information
Registered date
| 2024 | Year | 08 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063101
