UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Corneal sensitivity in dry eye
Title of the study (Brief title)	Corneal sensitivity in dry eye
Region	Japan

Condition
Condition	dry eye
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between dry eye symptoms and corneal sensitivity to mechano-, pain- and cold-stimuli
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sensitivity to mechano-, pain- and cold-stimuli
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	the subjects who agreed this study
Key exclusion criteria	subjects with ocular diseases without dry eye subjects with contact lens use eyes with lacrimal punctal plugs eyes with keratoconjunctival epithelial damage subjects who underwent ophthalmic surgery within 6 months subjects who can not understand and agree the study protocol
Target sample size	80

Research contact person
Name of lead principal investigator	Motoko Kawashima
Organization	Haneginomori Eye Clinic
Division name	Ophthalmology
Address	Shirota 4-26-4, Setagaya-ku, Tokyo, Japan
TEL	0362658777
Email	satchin0809@gmail.com

Public contact
Name of contact person	Minako Kaido
Organization	Wada Eye Clinic
Division name	Ophthalmology
Address	Hojyo 2578-27, Tateyama-shi, Chiba, Japan
TEL	0470-22-6311
Homepage URL
Email	w.kontact@ak.wakwak.com

Sponsor
Institute	Haneginomori Eye Clinic
Institute
Department

Funding Source
Organization	n/a
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Yoshino Eye Clinic
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	2017 Year 11 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 12 Month 15 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	n/a

Management information
Registered date	2017 Year 11 Month 17 Day
Last modified on	2018 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034280