UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058693 |
|---|---|
| Receipt number | R000067087 |
| Scientific Title | Post-hoc analysis of Myopia progression after discontinuation of Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan |
| Date of disclosure of the study information | 2025/08/04 |
| Last modified on | 2025/08/04 17:52:32 |
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Basic information
Public title
Post-hoc analysis of Myopia progression after discontinuation of Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan
Acronym
Post-hoc analysis of Myopia progression after discontinuation of Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan
Scientific Title
Post-hoc analysis of Myopia progression after discontinuation of Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan
Scientific Title:Acronym
Post-hoc analysis of Myopia progression after discontinuation of Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using data of subjects that continued to treatment period II in Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan, we will examine the changes in cycloplegic objective spherical equivalent (SE) and axial length (AL) after switching from 0.01% or 0.025% DE-127 ophthalmic solution to placebo ophthalmic solution, as well as demographic and other factors that may influence these changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in SE and AL by subject characteristics
Proportion of categories of annual changes in SE and AL
Examination of subject characteristic factors associated with changes in SE and AL
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
None
Target sample size
211
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 Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
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 Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
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
Research Ethics Committee, Santen Pharmaceutical Co., Ltd.
Address
4-20, Ofukacho, Kita-ku, Osaka
Tel
06-6321-7000
clinical@santen.co.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
| 2025 | Year | 08 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Post-hoc analysis of the Phase II/III clinical trial of Atropine sulfate (DE-127) ophthalmic solution
Management information
Registered date
| 2025 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067087
