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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036705
Receipt No. 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 2019/05/14

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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
Email 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
Email reisakata-tky@umin.ac.jp

Sponsor
Institute Yotsuya Shirato Eye Clinic
Institute
Department

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
Email 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
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 Open public recruiting
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 14 Day
Last follow-up date
2020 Year 10 Month 31 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
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041801

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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