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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023862
Receipt No. R000027484
Scientific Title A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Date of disclosure of the study information 2016/09/07
Last modified on 2019/03/08

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Basic information
Public title A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Acronym A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Scientific Title A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Scientific Title:Acronym A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Region
Japan

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

Objectives
Narrative objectives1 To investigate and compare efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops in patients with primary open angle glaucoma or ocular hypertension in a multi-center exploratory clinical study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IOP Change from baseline at the end of treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tapcom combination ophthalmic solution, QD for 12weeks
Interventions/Control_2 Xalacom combination eye drops, QD for 12weeks
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 who can visit the hospital according to the observation/test schedule determined in the study protocol
Those with disease of which the principal investigator or subinvestigator considers requiring treatment by using a fixed dose combination drug containing a prostaglandin and a beta blocker.
Key exclusion criteria There is risk of visual field disorder drastically progressing during the study period.
Has retinal which may aggravate during the study period.
Has active extraocular disease, inflammation or infection of the eye or eyelids
Has corneal abnormalities or other diseases which would prohibit accurate IOP measurement by Goldmann applanation tonometer
Has undergone LASIK surgery
Patients who are contraindicated to beta blockers (those who with bronchial asthma or insufficiently controlled heart failure)
Patients with allergy to the ingredients used in the present study
Female who is pregnant, lactating, or may possibly be pregnant , wishes to become pregnant during the study period, or cannot use appropriate contraceptive method.
Target sample size 150

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, 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, 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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 07 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 04 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Medical Adviser, Yasuaki Kuwayama, Fukushima eye clinic(Osaka)

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027484

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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