UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the tear secretion's function with new strip meniscometry tube: Influence of antiglaucoma eye drops to tear film and ocular surface part 2
Title of the study (Brief title)	Influence of antiglaucoma eye drops to tear film and ocular surface
Region	Japan

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

Objectives
Narrative objectives1	To investigate the influence of antiglaucoma eye drops to tear film and ocular surface
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination of tear with strip meniscometry tube
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	10 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patients who need to check their visual field
Key exclusion criteria	The patients who do not want to check the test
Target sample size	500

Research contact person
Name of lead principal investigator	Tetuju Sekiryu
Organization	Fukushima medical university school of medicine
Division name	Department of ophthalmology
Address	1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295, Japan.
TEL	024-547-1111
Email	sekiryu@fmu.ac.jp

Public contact
Name of contact person	Sagara Hideto
Organization	Marui Eye Clinic
Division name	Director
Address	1-83-3, Honjinmae Haramachi-ku, Minamisouma City, Fukushima Prefecture 975-0062, Japan
TEL	0244-24-0101
Homepage URL
Email	hide1234@ruby.ocn.ne.jp

Sponsor
Institute	Department of ophthalmology, Fukushima medical university school of medicine
Institute
Department

Funding Source
Organization	Marui Eye Clinic, Echo Electricity Co. Ltd.
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	2014 Year 05 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 05 Day
Anticipated trial start date	2014 Year 05 Month 10 Day
Last follow-up date	2018 Year 10 Month 01 Day
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	We check the amount of tear with strip meniscometry tube in glaucoma patients who have been treated with antiglaucoma eye drops.

Management information
Registered date	2014 Year 05 Month 07 Day
Last modified on	2018 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016202