UMIN-CTR Clinical Trial

Basic information
Public title	The exploratory observational study on the safety of Dormolol combination ophthalmic solution wakamoto under medical practice.
Acronym	The observational study on the safety of Dormolol combination ophthalmic solution wakamoto.
Scientific Title	The exploratory observational study on the safety of Dormolol combination ophthalmic solution wakamoto under medical practice.
Scientific Title:Acronym	The observational study on the safety of Dormolol combination ophthalmic solution wakamoto.
Region	Japan

Condition
Condition	Glaucoma Ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Dormolol combination ophthalmic solution wakamoto on glaucoma or ocular hypertension under medical practice in this exploratory observational study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Side effects: types, incidence rates
Key secondary outcomes	Intraocular pressure(IOP): IOP value, Mean IOP reduction from baseline at all measurement points, percentage change from baseline

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	Not applicable
Key exclusion criteria	Not applicable
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Sakata
Organization	Wakamoto Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
Zip code	103-8330
Address	2-2-2, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
TEL	03-3279-0958
Email	cli-trial@wakamoto-pharm.co.jp

Public contact
Name of contact person	1st name Seiji Middle name Last name Kurosawa
Organization	Wakamoto Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
Zip code	103-8330
Address	2-2-2, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
TEL	03-3279-0958
Homepage URL
Email	cli-trial@wakamoto-pharm.co.jp

Sponsor
Institute	Wakamoto Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Wakamoto Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Inouye Eye Hospital Ochanomizu Inouye Eye Clinic Ezure Eye Clinic Sugahara Eye Clinic Ueda Eye Clinic Goto Eye Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Wakamoto Pharmaceutical Co., Ltd.
Address	2-2-2, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8330, Japan
Tel	03-3279-0684
Email	hanaoka@wakamoto-pharm.co.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	井上眼科病院（東京都） お茶の水・井上眼科クリニック（東京都） えづれ眼科（東京都） 菅原眼科クリニック（東京都） うえだ眼科クリニック（東京都） 後藤眼科（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 03 Day

Related information
URL releasing protocol	https://www.shinryo-to-shinyaku.com/
Publication of results	Published

Result
URL related to results and publications	https://www.shinryo-to-shinyaku.com/
Number of participants that the trial has enrolled	98
Results	Not listed
Results date posted	2022 Year 10 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Not listed
Participant flow	Not listed
Adverse events	Not listed
Outcome measures	Not listed
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 28 Day
Date of IRB	2020 Year 04 Month 23 Day
Anticipated trial start date	2020 Year 06 Month 08 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective clinical study using existing hospital medical records.

Management information
Registered date	2020 Year 06 Month 02 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046119