UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016885 |
|---|---|
| Receipt number | 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 18:46:48 |
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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
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
nshoji@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019601
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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