UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence that low-concentrated muscarinic receptor inhibition eye drops give to an eyeball
Title of the study (Brief title)	Influence on eyeball of low-concentrated atropine
Region	Japan

Condition
Condition	The volunteer that adjustment powers not to have eye disease except the ametropia are enough
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	I investigate the action to an eyeball of the low-concentrated atropine instillation thoroughly.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Pupil diameter Accommodation
Key secondary outcomes	Wavefront aberration Axial length

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	0.1% atropine instillation
Interventions/Control_2	0.05% atropine instillation
Interventions/Control_3	0.025% atropine instillation
Interventions/Control_4	0.01% atropine instillation
Interventions/Control_5	0.005% atropine instillation
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	35 years-old >
Gender	Male and Female
Key inclusion criteria	accommodation enough
Key exclusion criteria	a whole body disease and eye disease except the ametropia
Target sample size	6

Research contact person
Name of lead principal investigator	Shigeru Kinohsita
Organization	Kyoto Prefectrural University of Medicine
Division name	ophthalmology
Address	465, Kajiicho in Kawaramachi, Kamigyo-ku, Kyoto-City, Japan
TEL	075-251-5578
Email	shigeruk@koto.kpu-m.ac.jp

Public contact
Name of contact person	Osamu Hieda
Organization	Kyoto Prefectrural University of Medicine
Division name	ophthalmology
Address	465, Kajiicho in Kawaramachi, Kamigyo-ku, Kyoto-City, Japan
TEL	075-251-5578
Homepage URL
Email	ohieda@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectrural University of Medicine
Institute
Department

Funding Source
Organization	Grants for Scientific Research
Organization
Division
Category of Funding Organization	Self funding
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 05 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 20 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	Partially published
URL releasing results
Results	The effect duration of the low-concentrated atropine was relatively short The effect to a pupil is present
Other related information

Management information
Registered date	2013 Year 05 Month 18 Day
Last modified on	2016 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012571