UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016465
Receipt No. R000017614
Scientific Title Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Date of disclosure of the study information 2015/02/06
Last modified on 2017/08/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Acronym Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Scientific Title Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Scientific Title:Acronym Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
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 examine safety and efficacy of TAPCOM combination ophthalmic solution (tafluprost/timolole maleate ophthalmic solution) switched from Xalatan Ophthalmic Solution 0.005% (latanoprost ophthalmic solution 0.005%) in patients with primary open angle glaucoma or ocular hypertension
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction of intraocular pressure
Topical and systemic adverse event

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 switch Xalatan 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 Patients whose IOP control with the monotherapy of Xalatan is considered insufficient by the investigator and patients with primary open angle glaucoma or ocular hypertension
Patients who can submit informed consent in writing and visit the hospital according to the observation/test schedule determined in the study protocol
Key exclusion criteria Patients with allergy to the ingredients used in the present study
Patients who are contraindicated to Beta blockers
Patients who the investigator consider ineligible for enrollment
Target sample size 85

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Hiroshima University Hospital
Division name Ophthalmology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5247
Email ykiuchi@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Okumichi
Organization Hiroshima University Hospital
Division name Ophthalmology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5247
Homepage URL
Email okumic@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
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 広島大学病院(広島県)hiroshima University Hospital (Hiroshima Pref.) 
白井病院(香川県) Shirai Eye Hospital (Kagawa Pref.)
広島記念病院(広島県) Hiroshima Memorial Hospital (Hiroshima Pref.)
金光病院(岡山県) Konko Hospital (Okayama Pref.)
ツカザキ病院(兵庫県) Tsukazaki Hospital (Hyogo Pref.)
広島総合病院(広島県) Hiroshima General Hospital (Hiroshima Pref.)
県立広島病院(広島県) Hiroshima Prefectural Hospital (Hiroshima Pref.)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.dovepress.com/articles.php?article_id=33383
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
2014 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 25 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
2015 Year 02 Month 06 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.