UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution switched from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5%.
Title of the study (Brief title)	IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution switched from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5%.
Region	Japan

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

Objectives
Narrative objectives1	To investigate IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution in primary open angle glaucoma patients who switch treatment from Tapros ophthalmic solution 0.015% and Timoptol XE ophthalmic solution 0.5%.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean 24-hr IOP
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 ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5% 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	Patients with unilateral or bilateral primary open angle glaucoma Patients who can visit the hospital according to the observation/test schedule determined in the study protocol
Key exclusion criteria	Patients with some corneal abnormality or other diseases which may interfere with accurate IOP measurement using Goldmann applanation tonometer Patients with a history of corneal refractive surgery Patients with active extraocular disease, inflammation or infection in the eye(s) or eyelid(s) Patients with allergy to the ingredients used in the present study Pregnant, lactating women or women who may be pregnant, and women who wish to be pregnant or can not conduct appropriate contraception during the study period Patients who are contraindicated to beta blockers (those who with bronchial asthma or insufficiently controlled heart failure)
Target sample size	20

Research contact person
Name of lead principal investigator	Masayo Hashimoto
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs Group, Development Management Department, Japan Business
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9337
Email	clinical@santen.co.jp

Public contact
Name of contact person	Naomi Otsuka
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs Group, Development Management Department, Japan Business
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)

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　信濃会　信濃坂クリニック（東京都）/ Medical Corporation Shinanokai SHINANOZAKA CLINIC (Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 05 Day
Anticipated trial start date	2016 Year 08 Month 10 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
Results
Other related information

Management information
Registered date	2016 Year 09 Month 01 Day
Last modified on	2018 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027491