UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056449 |
|---|---|
| Receipt number | R000064462 |
| Scientific Title | A Study of the Continuation Rate of Glaucoma Eye Drop Medication by Combination Medication (Longitudinal Study Using Medical Fee Detailed Data) |
| Date of disclosure of the study information | 2024/12/19 |
| Last modified on | 2025/10/22 09:54:31 |
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Basic information
Public title
A Study of the Continuation Rate of Glaucoma Eye Drop Medication by Combination Medication
Acronym
A Study of the Continuation Rate of Glaucoma Eye Drop Medication by Combination Medication
Scientific Title
A Study of the Continuation Rate of Glaucoma Eye Drop Medication by Combination Medication (Longitudinal Study Using Medical Fee Detailed Data)
Scientific Title:Acronym
A Study of the Continuation Rate of Glaucoma Eye Drop Medication by Combination Medication (Longitudinal Study Using Medical Fee Detailed Data)
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the actual situation of combination patterns and treatment continuation rates in glaucoma patients using combination glaucoma eye drops.
Basic objectives2
Others
Basic objectives -Others
Continuation rate
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Continuation rate of glaucoma eye drops in glaucoma patients
Key secondary outcomes
Continuation rate of monotherapy with glaucoma eye drops in glaucoma patients
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with glaucoma or ocular hypertension (ICD10 code H40. Excluding glaucoma included in H402, H405: "Angiogenic glaucoma" and H400: "Primary angle-closure glaucoma") during the inclusion period and started concomitant therapy with the target drug (monotherapy for some secondary outcomes) in the same month
Patients who are 18 years of age or older as of the index date
Key exclusion criteria
None
Target sample size
66206
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
540-0021
Address
3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan
TEL
06-6943-7722
Matsukawa.Miyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Rikiya |
| Middle name | |
| Last name | Toda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
16-4, Konan 2-chome, Minato-ku, Tokyo Shinagawa Grand Central Tower 13F 108-8242, Japan
TEL
06-6943-7722
Homepage URL
Toda.Rikiya.a@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka 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
NA
Address
NA
Tel
NA
NA
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 | 12 | Month | 19 | 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
28560
Results
When combined with CAR/LAT, treatment continuation rates were higher for brimonidine, brinzolamide, and their fixed-dose combination. Continuation rates declined as the number of components and bottles increased. The one-year continuation for combination glaucoma therapy ranged from the high teens to about 30%, indicating that duration varied by combination pattern, component count, bottle count, hospital size, and initial treatment period.
Results date posted
| 2025 | Year | 10 | Month | 22 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The continuation rate of glaucoma eye drops in glaucoma patients is examined by the number of ingredients, the number of bottles, and the combination pattern.
Management information
Registered date
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064462
