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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name