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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016231
Receipt No. R000018834
Scientific Title Evaluation of the efficacy of warming by using commercially-available hot eye masks for normal and dry eye patients
Date of disclosure of the study information 2015/01/16
Last modified on 2018/01/18

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Basic information
Public title Evaluation of the efficacy of warming by using commercially-available hot eye masks for normal and dry eye patients
Acronym The efficacy of warming by hot eye mask
Scientific Title Evaluation of the efficacy of warming by using commercially-available hot eye masks for normal and dry eye patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Reiko Arita
Organization Itoh clinic
Division name Ophtalmology
Zip code
Address 626-11, Minaminakano, Minuma-Ku, Saitama
TEL 048-686-5588
Email ritoh@za2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Arita
Organization Itoh Clinic
Division name Ophthalmology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 12 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000018834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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