UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028662 |
|---|---|
| Receipt number | R000032578 |
| Scientific Title | Effects of daily warming therapies on ocular surface factors and QOL scores |
| Date of disclosure of the study information | 2017/08/19 |
| Last modified on | 2019/03/19 12:02:48 |
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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
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
motoko326@gmail.com
Public contact
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
uchinomiki@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032578
