UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055608 |
|---|---|
| Receipt number | R000063542 |
| Scientific Title | Effects of Blinking Exercise |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2024/09/25 00:44:45 |
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Basic information
Public title
Effects of Blinking Exercise on Palpebral Fissure Height and Tear Film Parameters
Acronym
Effects of Blinking Exercise
Scientific Title
Effects of Blinking Exercise
Scientific Title:Acronym
Effects of Blinking Exercise
Region
| Japan |
Condition
Condition
Dry Eye, Healthy Volunteers
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Each time we blink, the meibomian glands secrete lipids (meibum) onto the ocular surface, spreading the tear film. Meibum helps prevent tear evaporation, stabilizes the tear film, and promotes its distribution. During eye opening, tear fluid evaporates. Incomplete blinking occurs when the upper and lower eyelids don't fully touch, increasing tear evaporation. Studies show that blinking exercises reduce incomplete blinking and improve symptoms of dry eye and non-invasive tear break-up time (NIBUT) (Kim AD, et al., 2021). Although patients reported easier eyelid opening, the effect of blinking exercises on eyelid opening has not been documented. To assess this, we measured palpebral fissure height as indicators, alongside subjective symptoms and tear stability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
palpebral fissure height (mm)
Key secondary outcomes
Subjective Symptoms
SPEED Score: Evaluates the frequency and severity of dry eye symptoms, scoring from 0 to 28.
Visual Analog Scale (VAS): Independently rates 8 symptoms (dryness, eye fatigue, discomfort, blurred vision, foreign body sensation, pain, heaviness, difficulty opening eyes) from 0 (no symptoms) to 100 (maximum symptoms).
Measurements using idra
Tear lipid layer thickness (nm)
Tear meniscus height (mm)
Blink quality (%), complete/incomplete blinks, duration (seconds)
Non-invasive tear break-up time (NIBUT first, average) (seconds)
Corneal and conjunctival epithelial damage score: Assessed using fluorescein staining (0-9).
Tear film break-up time with fluorescein (FBUT) (seconds): Average of 3 measurements.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Blinking Exercise
Interventions/Control_2
Artifical Tears
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age: 18 years or older, but under 60 at the time of consent.
Gender: No restrictions.
Ability: Must be able to personally complete and sign the consent form.
Key exclusion criteria
Patients with acute eye or eyelid diseases
Obvious eyelid or ocular surface diseases (congenital eyelid abnormalities, entropion, ectropion, Sjogren's syndrome)
Thyroid eye disease or neurological conditions (e.g., oculomotor nerve palsy, myasthenia gravis, Horner's syndrome)
Use of anti-glaucoma eye drops
History of eyelid surgery (e.g., ptosis correction, blepharoplasty) or facial fractures
Daily use of hard contact lenses
Recent eye surgery,IPL,LipiFlow, Botox within 3 months
Ocular allergies during testing
Judged as unsuitable by the principal investigator or co-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
337-0042
Address
626-11, Minaminakano, Minumaku, Saitama City, Saitama
TEL
0486865588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
337-0042
Address
626-11, Minaminakano, Minumaku, Saitama City, Saitama
TEL
0486865588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Reiko Arita
Funding Source
Organization
Itoh Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Lid and meibomian gland working group
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Yamauchi Clinic
Address
1-15-19, Jiyugaoka, Meguroku, Tokyo
Tel
0337237717
fujii.tetsuya@neues.co.jp
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
伊藤医院、大宮はまだ眼科西口分院、レイクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 25 | 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
100
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
| 2023 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 07 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 11 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063542
