UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the eye drop bottles on the usability and visibility
Title of the study (Brief title)	Evaluation of the eye drop bottles on the usability and visibility
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the influence that the property of the eye drop bottles gives to the usability and visibility in glaucoma patients
Basic objectives2	Others
Basic objectives -Others	Usability
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall evaluation of scored usability and visibility of eye drop bottles
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1) Patients with glaucomatous visual field defect 2) Patients without experience of the use of eye drop bottles with the same design
Key exclusion criteria	Patients that cannot instill eye drops by themselves with disability
Target sample size	100

Research contact person
Name of lead principal investigator	Shiro Mizoue
Organization	Ehime University
Division name	Ophthalmology
Address	Shitsukawa, Toon-city, Ehime
TEL	089-960-5361
Email	mizoue@m.ehime-u.ac.jp

Public contact
Name of contact person	Tomoyuki Kamao
Organization	Ehime University
Division name	Ophthalmology
Address	Shitsukawa, Toon-city, Ehime
TEL	089-960-5361
Homepage URL
Email	t-kamao@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	SENJU 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	南松山病院（愛媛県）Minami-matsuyama Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 12 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	case series All glaucoma patients were examined who meet the selection criteria at Minami-matsuyama Hospital from December 2015 to March 2016. Evaluation of scored usability and visibility of eye drop bottles using questionnare

Management information
Registered date	2015 Year 12 Month 08 Day
Last modified on	2016 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023243