UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros 0.0015% and Timoptol XE 0.5% Solutions
Acronym	Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros and Timoptol XE Solutions
Scientific Title	Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros 0.0015% and Timoptol XE 0.5% Solutions
Scientific Title:Acronym	Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros and Timoptol XE Solutions
Region	Japan

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

Objectives
Narrative objectives1	To investigate effects of Tapcom combination ophthalmic solution on IOP and adherence in 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	IOP reduction
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, normal tension glucoma or ocular hypertension treatment with concomitant use of Tapros 0.0015%, Timoptol XE 0.5% ophthalmic solution and an anti-glaucoma drug
Key exclusion criteria	some corneal abnormality or other diseases which may interfere with accurate IOP measurement history of corneal refractive surgery bronchial asthma or a history of the said disease bronchospasm or severe chronic obstructive pulmonary disease cardiac insufficiency, sinus bradycardia, atrioventricular block (II, or III degree) or cardiogenic shock
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Shoji
Organization	Kitasato University
Division name	Department of Ophthalmology, School of Medicine
Zip code	252-0374
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan
TEL	042-778-9735
Email	nshoji@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Shoji
Organization	Kitasato University
Division name	Department of Ophthalmology, School of Medicine
Zip code	252-0374
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan
TEL	042-778-9735
Homepage URL
Email	nshoji@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
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	The Institutional Review Board of Kitasato University Hospital
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan
Tel	042-778-7756
Email	rinri@med.kitasato-u.ac.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

北里大学病院（神奈川県）/ Kitasato University Hospital (Kanagawa Pref.) 独立行政法人　地域医療機能推進機構　相模野病院（神奈川県）/ Japan Community Health care Organazation Sagamino Hospital (Kanagawa Pref.) とうめい厚木クリニック（神奈川県）/ Tomei Atsugi clinic (Kanagawa Pref.) 大和市立病院（神奈川県）/ Yamato Municipal Hospital (Kanagawa Pref.) 東芝林間病院（神奈川県）/ Toshiba Rinkan Hospital (Kanagawa Pref.) 神奈川歯科大学附属横浜クリニック（神奈川県）/ Kanagawa Dental University Yokohama Clinic (Kanagawa Pref.)

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 23 Day

Related information
URL releasing protocol	Not applicable
Publication of results	Published

Result
URL related to results and publications	https://www.scirp.org/Journal/paperinformation.aspx?paperid=96213
Number of participants that the trial has enrolled	30
Results	Refer to published paper
Results date posted	2020 Year 03 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 11 Month 06 Day
Baseline Characteristics	Refer to published paper
Participant flow	Refer to published paper
Adverse events	Refer to published paper
Outcome measures	Refer to published 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	2015 Year 01 Month 19 Day
Date of IRB	2015 Year 02 Month 18 Day
Anticipated trial start date	2015 Year 03 Month 14 Day
Last follow-up date	2016 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 23 Day
Last modified on	2020 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019601

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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