UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of IOP reduction and safety of Tapcom combination ophthalmic solution switched from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution.
Title of the study (Brief title)	Efficacy of IOP reduction and safety of Tapcom combination ophthalmic solution switched from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution.
Region	Japan

Condition
Condition	primary open angle glaucoma or ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy of IOP reduction and safety of Tapcom combination ophthalmic solution switched from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IOP reduction Adverse event
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Switching from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution to Tapcom combination ophthalmic solution
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	primary open angle glaucoma or ocular hypertension good adherence before the study initiation
Key exclusion criteria	some corneal abnormality or other diseases which may interfere with accurate IOP measurement history of glaucoma surgery contraindicated to Beta blockers
Target sample size	30

Research contact person
Name of lead principal investigator	1.Kenji Inoue 2.Masayo Hashimoto
Organization	1.Inouye Eye Hospital 2.Santen Pharmaceutical Co., Ltd.
Division name	1.Medical office 2.Japan Medical Affairs Group, Development Management Department, Japan Business
Address	1.4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan 2. 4-20, Ofukacho, Kita-ku, Osaka
TEL	1.03-3295-0911
Email	1.study@inouye-eye.or.jp

Public contact
Name of contact person	Kenji Inoue
Organization	Inouye Eye Hospital
Division name	Medical office
Address	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan
TEL	03-3295-0911
Homepage URL
Email	study@inouye-eye.or.jp

Sponsor
Institute	Inouye Eye Hospital
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)

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	医療法人社団　済安堂　お茶の水・井上眼科クリニック（東京都）/ Medical Corporation Saiando Ochanomizu Inouye eye clinic

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 06 Day
Anticipated trial start date	2014 Year 12 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.2147/OPTH.S150595
Results
Other related information

Management information
Registered date	2014 Year 12 Month 25 Day
Last modified on	2018 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018656