UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040040
Receipt number R000045651
Scientific Title Multicenter retrospective study focusing on efficacy and safety of Omidenepag isopropyl
Date of disclosure of the study information 2020/04/15
Last modified on 2022/04/27 10:17:27

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Basic information

Public title

Retrospective study focusing on efficacy and safety of Omidenepag isopropyl

Acronym

Omidenepag isopropyl Retrospective study

Scientific Title

Multicenter retrospective study focusing on efficacy and safety of Omidenepag isopropyl

Scientific Title:Acronym

Multicenter retrospective study of Omidenepag isopropyl

Region

Japan


Condition

Condition

Glaucoma or Ocular hypertension

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this multicenter retrospective study is to evaluate efficacy and safety of Omidenepag isopropyl in glaucoma or ocular hypertension patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IOP-lowering effect

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All glaucoma or ocular hypertension patients who were newly treated with Omidenepag isopropyl during observational period

Key exclusion criteria

There is no exclusion criteria in this study.

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Kiyotaka
Middle name
Last name Hori

Organization

Santen Pharmaceutical Co. Ltd.

Division name

Japan Medical Affairs

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9603

Email

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

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9603

Homepage URL


Email

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

Sapporo Yurinokai Hospital IRB

Address

11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido

Tel

011-771-1501

Email

info@yurinokai.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

2020 Year 04 Month 15 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s12325-022-02069-6

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s12325-022-02069-6

Number of participants that the trial has enrolled

827

Results

Refer to paper

Results date posted

2022 Year 04 Month 27 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

The datasets are not publicly available, but are available from the corresponding author on reasonable request.

IPD sharing Plan description

The datasets are not publicly available, but are available from the corresponding author on reasonable request.


Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 03 Month 03 Day

Date of IRB

2020 Year 03 Month 25 Day

Anticipated trial start date

2020 Year 07 Month 06 Day

Last follow-up date

2021 Year 05 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is retrospective clinical study using existing hospital medical records.


Management information

Registered date

2020 Year 04 Month 03 Day

Last modified on

2022 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045651


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name