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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023883
Receipt No. R000027491
Scientific 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%.
Date of disclosure of the study information 2016/09/08
Last modified on 2018/03/16

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Basic information
Public 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%.
Acronym 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%.
Scientific 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%.
Scientific Title:Acronym 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
1st name
Middle name
Last name Masayo Hashimoto
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
Address 4-20, Ofukacho, Kita-ku, Osaka
TEL 06-4802-9337
Email clinical@santen.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Otsuka
Organization Santen Pharmaceutical Co., Ltd.
Division name Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027491

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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