UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016231 |
|---|---|
| Receipt number | 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 09:34:38 |
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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
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
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018834
