UMIN-CTR Clinical Trial

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
Institute	Santen Pharmaceutical Co. Ltd.
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045651