UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016885
Receipt No. R000019601
Scientific Title Effects of Tapcom Combination Ophthalmic Solution Switched from Tapros 0.0015% and Timoptol XE 0.5% Solutions
Date of disclosure of the study information 2015/03/23
Last modified on 2020/03/10 (Ver. 7)

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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/icdr_e/ctr_view.cgi?recptno=R000019601