UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therapeutic outcome of unoprostone and nipradilol in patients with normal tension glaucoma.
Title of the study (Brief title)	Therapeutic outcome of unoprostone and nipradilol
Region	Japan

Condition
Condition	normal tension glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the ocular hypotensive effect
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intraocular pressure
Key secondary outcomes	The incidence rate of side effect

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	drug intervention
Interventions/Control_2	drug intervention
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	normal tension glaucoma
Key exclusion criteria	neuro-ophthalmic disease and chorioretinopathy patients
Target sample size	50

Research contact person
Name of lead principal investigator	Takayuki Kanda
Organization	National Defense Medical College
Division name	Department of Ophthalmology
Address	3-2, Namiki, Tokorozawa, Saitama
TEL	04-2995-1683
Email	kankan@ndmc.ac.jp

Public contact
Name of contact person	Takayuki Kanda
Organization	National Defense Medical College
Division name	Department of Ophthalmology
Address	3-2, Namiki, Tokorozawa, Saitama
TEL	04-2995-1683
Homepage URL
Email	kankan@ndmc.ac.jp

Sponsor
Institute	Department of Ophthalmology, National Defense Medical College
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2013 Year 09 Month 17 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 07 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 17 Day
Last modified on	2017 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013769