UMIN-CTR Clinical Trial

Basic information
Public title	Effect of brimonidine on the ocular circulation
Acronym	Effect of brimonidine on the ocular circulation
Scientific Title	Effect of brimonidine on the ocular circulation
Scientific Title:Acronym	Effect of brimonidine on the ocular circulation
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of brimonidine on the ocular circulation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Retinal blood flow
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Measurement of the retinal blood flow by Doppler optical coherence tomography (DOCT) (Before start brimonidine and 3 months after start brimonidine)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Subjects able to understand the written informed consent and willing to participate evidenced by signing the informed consent 2)Glaucomatous changes in the fundus 3)Abnormal glaucomatous visual field according to the Anderson-Patella classification in the Swedish interactive threshold algorithm (SITA)-standard strategy of the 30-2 program of the Humphrey field analyzer (HFA) 4)Subjects administered with additional brimonidine
Key exclusion criteria	1)Cataract and previous cataract surgery 2)High ametropia 3)Subjects with cardiovascular disease such as untreated hypertension and diabetes mellitus 4)Previous ocular surgery 5)Difficulty for perform examination
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seigo Nakabayashi
Organization	Asahikawa Medical University
Division name	Ophthalmology
Zip code
Address	2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan
TEL	0166-68-2543
Email	nby@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takayuki Kamiya
Organization	Asahikawa Medical University
Division name	Ophthalmology
Zip code
Address	2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan
TEL	0166-68-2543
Homepage URL
Email	t-kamiya@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Asahikawa Medical University
Organization
Division
Category of Funding Organization	Other
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	2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 06 Month 26 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	2017 Year 06 Month 19 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031835

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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