UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective clinical research on safety and efficacy of TAPCOM Combination Ophthalmic Solution switched from Xalatan Ophthalmic Solution
Title of the study (Brief title)	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	Yoshiaki Kiuchi
Organization	Hiroshima University Hospital
Division name	Ophthalmology
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5247
Email	ykiuchi@hiroshima-u.ac.jp

Public contact
Name of contact person	Hideaki Okumichi
Organization	Hiroshima University Hospital
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.dovepress.com/articles.php?article_id=33383
Results
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