UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Switching from latanoprost or travoprost ophthalmolic solution to tafruprost and timolol fixed ophthalmic solution
Title of the study (Brief title)	Switching from latanoprost or travoprost to tafruprost and timolol fixed ophthalmic solution
Region	Japan

Condition
Condition	Primary open angle glaucoma and ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of tafloprost and timolol fixed combination by switching latanoprost or travoprost monotherapy
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 effects
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 latanoprost or travoprost monotherapy to tafluprost/timolol fixed combination
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Primary open angle glaucoma Ocular hypertension
Key exclusion criteria	Severe respiratory diseases Severe systemic diseases Allegic reaction against contents of the experimental compounds
Target sample size	40

Research contact person
Name of lead principal investigator	Kenji Kashiwagi
Organization	University of Yamanashi
Division name	Ophthalmology
Address	1110 Shimokato Chuo Yamanashi
TEL	055-273-1111
Email	kenjik@yamanashi.ac.jp

Public contact
Name of contact person	Kenji Kashiwagi
Organization	University of Yamanashi
Division name	Ophthalmology
Address	1110 Shimokato Chuo Yamanashi
TEL	055-273-1111
Homepage URL
Email	kenjik@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Santen Pharmaceitical 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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 05 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 11 Month 20 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2016 Year 02 Month 29 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 02 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018087