UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036705 |
|---|---|
| Receipt number | R000041801 |
| Scientific Title | An observational study focusing on the changes of the upper eyelid sulcus after switching from FP receptor agonist to EP2 receptor agonist |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2023/04/20 16:15:55 |
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Basic information
Public title
An observational study focusing on the changes of the upper eyelid sulcus after switching from FP receptor agonist to omidenepag isoproryl ophthalmic solution
Acronym
An observational study focusing on the changes the upper eyelid sulcus after switching to omidenepag isoproryl ophthalmic solution
Scientific Title
An observational study focusing on the changes of the upper eyelid sulcus after switching from FP receptor agonist to EP2 receptor agonist
Scientific Title:Acronym
An observational study focusing on the changes the upper eyelid sulcus after switching to EP2 receptor agonist
Region
| Japan |
Condition
Condition
Glaucoma, ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes of the upper eyelid sulcus and to assess the QOL after switching from FP receptor agonist to omidenepag isopropyl ophthalmic solution 0.002% for glaucoma or ocular hypertension patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of findings and subjective symptom and quality of life about the upper eyelid sulcus
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) a patient with glaucoma or ocular hypertension
2) a patient treats FP receptor agonist for glaucoma or ocular hypertension
3) a patient who has a desire to change their eyedrops because of impaired quality of life due to the deepening of the upper eyelid sulcus after topical use of FP receptor agonist. And that is the case where it seems to be appropriate to switch from FP receptor agonist to omidenepag isopropyl ophthalmic solution 0.002% by the research group
4) an outpatient
Key exclusion criteria
1) a patient with aphakic or pseudophakic eyes
2) a patient with hypersensitivity to Omidenepag isopropyl ophthalmic solution 0.002%
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Aihara |
Organization
Yotsuya Shirato Eye Clinic
Division name
Ophthalmology
Zip code
160-0004
Address
Yotsuya Mitsuke building 3F, 1-1-2, Yotsuya, Shinjyuku-ku, Tokyo
TEL
03-3355-4281
aihara-tky@umin.net
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Sakata |
Organization
Yotsuya Shirato Eye Clinic
Division name
Ophthalmology
Zip code
160-0004
Address
Yotsuya Mitsuke building 3F, 1-1-2, Yotsuya, Shinjyuku-ku, Tokyo
TEL
03-3355-4281
Homepage URL
reisakata-tky@umin.ac.jp
Sponsor or person
Institute
Yotsuya Shirato Eye Clinic
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-3, Kichijoji Kitamachi, Musashino-shi, Tokyo
Tel
070-5011-8550
shingo-namiki@j-smo.com
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
| 2019 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36318495/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36318495/
Number of participants that the trial has enrolled
23
Results
https://pubmed.ncbi.nlm.nih.gov/36318495/
Results date posted
| 2023 | Year | 04 | Month | 20 | 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
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the changes of the upper eyelid sulcus and to assess the QOL after switching from FP receptor agonist to omidenepag isopropyl ophthalmic solution 0.002% for glaucoma or ocular hypertension patients
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041801
