UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy of warming by using commercially-available hot eye masks for normal and dry eye patients
Title of the study (Brief title)	The efficacy of warming by hot eye mask
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of hot eye mask on improvement of dry eye symptoms, we applied commercially-available eye hot mask to the normal subjects and dry eye patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ocular symptoms, slitlamp micrography, corneaconjunctival epithalial disorders, non-contact meibography
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	hot eye mask without menthol, 10 minutes, single application
Interventions/Control_2	hot eye mask with menthol, 10 minutes, single application
Interventions/Control_3	hot eye mask without menthol, 10 minutes, repeat application for two weeks
Interventions/Control_4	hot eye mask with menthol, 10 minutes, repeat application for two weeks
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	45 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects of dry eye symptoms with DEQS questionnaire score over than 30 points. Subjects obtained written informed consent Soft contact lens users Subjects without any past history of contact lens wearing Subjects who diagnosed as definite dry eye or dry eye suspected based on the criteria determined by Dry eye society in Japan.
Key exclusion criteria	Subjects with ocular diseases except dry eye Subjects with any other diseases which requires treatments Subjects with allergy reaction to warming Subjects with applying any eye drops Subjects who does not like the menthol smell.
Target sample size	80

Research contact person
Name of lead principal investigator	Reiko Arita
Organization	Itoh clinic
Division name	Ophtalmology
Address	626-11, Minaminakano, Minuma-Ku, Saitama
TEL	048-686-5588
Email	ritoh@za2.so-net.ne.jp

Public contact
Name of contact person	Reiko Arita
Organization	Itoh Clinic
Division name	Ophthalmology
Address	626-11 Minaminakano, Minuma-Ku, Saitama
TEL	048-686-5588
Homepage URL
Email	ritoh@za2.so-net.ne.jp

Sponsor
Institute	Itoh clinic
Institute
Department

Funding Source
Organization	Itoh Clinic
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	2015 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 16 Day
Last modified on	2018 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018834