UMIN-CTR Clinical Trial

Basic information
Public title	Effects of daily warming therapies on ocular surface factors and QOL scores
Acronym	Effects of daily warming therapies on ocular surface factors and QOL scores
Scientific Title	Effects of daily warming therapies on ocular surface factors and QOL scores
Scientific Title:Acronym	Effects of daily warming therapies on ocular surface factors and QOL scores
Region	Japan

Condition
Condition	Subjects who experience dryness of eyes including dry eye disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of daily warming therapies on ocular surface factors, subjective symptoms and QOL scores, in addition to the survey of the relation between the ocular surface factors and subjective symptoms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of the tear film stability, DEQS(dry eye related quality of life score), SHS (Subjective Happiness Scale), HADS(Hospital Anxiety and Depression Scale), and McGill Pain Questionnaire after the 2- week repeated treatment with eye mask
Key secondary outcomes	Evaluation of the subjective symptoms of dry eyes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply the warming therapy for eye area for 10 minutes once a day for 2 weeks
Interventions/Control_2	Apply the placebo therapy for eye area for 10 minutes once a day for 2 weeks
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	Male and female subjects over 20 year old, who experience dryness of eyes on a daily basis
Key exclusion criteria	Demonstrate any of the following conditions on the eyes or skin around eyes; inflammation, visible irritation, rash, swelling, eczema, or any other abnormalities Are sensitive to thermal sense Have a diminished sensitivity to thermal sense Have had eye surgery within 1 month prior to the study Have, in the opinion of the Principal Investigator, an unacceptable condition
Target sample size	250

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Motoko Kawashima
Organization	Keio University
Division name	Department of Ophthalmology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL	+81-3-5363-3281
Email	motoko326@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Miki Uchino
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL	+81-3-5363-3281
Homepage URL
Email	uchinomiki@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	慶應義塾大学病院眼科（東京都）、杉田眼科（東京都）、羽根木の森アイクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 26 Day
Date of IRB	2017 Year 08 Month 29 Day
Anticipated trial start date	2017 Year 08 Month 30 Day
Last follow-up date	2019 Year 02 Month 14 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 15 Day
Last modified on	2019 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032578