Back to resultsEffects and Safety of Steam Eye Mask With Acupoints Stimulation
Primary Purpose
Dry Eye Symptom, Eye Fatigue
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Steam Eye Mask with acupoints stimulation
Steam Eye Mask
Sponsored by
About this trial
This is an interventional other trial for Dry Eye Symptom focused on measuring Steam Eye Mask, Acupoints Stimulation, Dry Eye Symptom, Eye Fatigue, Visual Display Terminal, Moist Heat, Massage
Eligibility Criteria
Inclusion Criteria:
- Males or females aged from 20 to 69 years old (both inclusive).
- Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day.
- Participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire.
- Participants who respond to more than 1 of 12 typical dry eye symptoms by "constantly" or "often" based on a dry eye questionnaire.
- Participants are able and willing to comply with all protocol requirements and procedures.
- Participants who must be capable of providing informed consent document, with one's signature.
Exclusion Criteria:
- Participants with eye diseases that could affect the ocular surface (e.g. Ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases).
- Participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease.
- Participants with the excessive meibomian lipid secretion (seborrheic MGD).
- Participants with trauma, swelling and eczema at the skin around eyes.
- Participants with allergic reaction for heating, abnormality of the heat or depression of the heat.
- Participants who are deemed inappropriate to participate in this study by physicians.
Sites / Locations
- Kao (Taiwan) Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Steam Eye Mask With Acupoints Stimulation
Steam Eye Mask
Arm Description
The Steam Eye Mask with acupoints stimulation (SEM with acupoints stimulation), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air. Also, on the eyebrow have the acupoints made by nonwoven fabric can use hands to massage. The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes and use hands to massage the acupoints on the eyebrows for the first 3 minutes.
The Steam Eye Mask (SEM), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air. The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes.
Outcomes
Primary Outcome Measures
Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants.
The severity of symptoms and mood state are evaluated using a VAS by each participant. A VAS is a horizontal line, 100mm in length, anchored by word descriptors at each end. Participants mark on the line the point that they feel their perception of their current state. The VAS score is determined by measuring the length from the left hand end of the line to the point that they mark. The five symptoms to be evaluated are: tiredness of eyes, dryness of eyes, grittiness of eyes, blurred vision, and ocular discomfort. Each symptom is relieved as the VAS score decreases. The mood states to be evaluated are: relaxation and comfort. Each mood state is enhanced as the VAS score increases.
Secondary Outcome Measures
The computer visual syndrome questionnaire (CVS-Q) evaluated by participants.
The computer vision syndrome questionnaire (CVS-Q) is applied to evaluate the visual health of workers exposed to the computer screen. This questionnaire consists of sixteen items with the response options of the severity (frequency and intensity) of each particular symptom and the overall symptom severity (CVS score). The score of each ocular discomfort is calculated by the frequency multiplies the intensity. The frequency for each symptom is answered by the subject as never, occasionally, and often/always which are coded as 0, 1, and 2, respectively. The intensity is defined for two options as 1 for moderate and 2 for intense, respectively. Moreover, the score obtained for each item will then be coded as 1 while the multiplied score is 1 or 2; and 2 while the multiplied score is 4. The results can be compared between different individuals or in the same individual at different times and circumstances. The higher score a subject gained, the worsen ocular condition he/she experienced.
Dry eye questionnaire evaluated by participants.
The dry eye questionnaire will be used for evaluate the dry eye symptom of each participant. This questionnaire consists of 12 typical dry-eye-related symptoms, include 1. Ocular fatigue, 2. Discharge, 3. Foreign body sensation, 4. Heavy sensation, 5. Dry sensation, 6. Uncomfortable sensation, 7. Excess tearing, 8. Blurred vision, 9. Itching, 10. Sensitivity to bright light, 11. Redness, 12. Pain. Each symptom will be evaluated from never, sometimes, often, and Constantly.
The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants.
The Dry-Eye-Related Quality of Life Score can assess various aspects of Quality of Life including its mental aspect. This questionnaire consists of 15 items related to dry eye symptoms(0 to 4, 0 as never, the less score as mild) and influence(1-4, the less score as rare) on daily life, and the overall degree of Quality of Life Score impairment is calculated as a summary score. The subject also grades the overall for the past week, including subject's eye symptoms and how they have affected subject's daily life, it will be graded from 1 to 6, the lower score means the subject is in better condition. DEQS score is decreased as Quality of Life Score is improved.
Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.
Tear Meniscus Height is observed with Oculus Keratograph 5M.
Tear film breakup time (TBUT) evaluated by an examiner.
Tear film breakup time is the parameter of tear film stability, defined as the time to initial breakup of the tear film after a blink.
Schirmer test evaluated by an examiner.
Schirmer test is an estimation of tear flow reflex by insertion of a filter paper into the conjunctival sac. This test is performed with the participants' eyes closed in 5 minutes.
Meibomian gland expression evaluated by an examiner.
Meibomian gland expression can be performed as an indicator of meibomian gland function, meibum expressibility and quality. The secretion expressed from the glands is observed with a physical force applied to the outer surface of the eyelid to determine whether a specific meibomian gland is functional and capable of providing secretion.
Visual acuity (VA) evaluated by an examiner.
The normal visual acuity is measured for both eyes separately using a Snellen chart.
Intraocular pressure (IOP) evaluated by an examiner.
The intraocular pressure is measured for both eyes separately using the tonometer.
Ocular surface/eyelids findings diagnosed by an examiner.
An ophthalmologist observes the cornea, conjunctiva, and eyelids for each participant and confirms whether there are any inflammation and hyperemia on the ocular surface or any other abnormalities on the ocular surface and eyelids before and after the application of IP.
The slit lamp is applied to evaluate the following 6 items for both eyes including 1. Lid Margin Irregularity, 2. Lid Margin Vascularity, 3. Meibomian Orifice Plugging, 4. Mucocutaneous J Retroplacement, 5. Surface Finding Cornea, and 6. Surface Finding Conjunctiva. And the clinical judgments of normal or abnormal among these items will then assess by the investigators.
Diary reported by a participant.
Participants are asked to record the time, date, place and adverse events, if there is, in a daily questionnaire after every use of IP. If there is any report of adverse events, an ophthalmologist determines the severity and the relationship of the adverse events to using IP.
Adverse events
All adverse events will be record, and the incidence rates will be calculated.
Staining of ocular surface evaluated by an examiner
Ocular surface damage is assessed by staining cornea and conjunctiva. The liquid of fluorescein is instilled by the micropipette to stain the ocular surface. The staining of ocular surface is graded on a scale of 0 to 3 on the cornea and both areas of the conjunctiva, and then summed (Total range in 0-9 points) for each eye, according to the van Bijsterveld system.
Full Information
NCT ID
NCT04584216
First Posted
September 28, 2020
Last Updated
October 6, 2020
Sponsor
Kao (Taiwan) Corporation
Collaborators
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04584216
Brief Title
Effects and Safety of Steam Eye Mask With Acupoints Stimulation
Official Title
Evaluation of the Effects and Safety by the Steam Eye Mask With Acupoints Stimulation for VDT User
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2020 (Actual)
Primary Completion Date
June 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kao (Taiwan) Corporation
Collaborators
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effects and safety of the steam eye mask with acupoints stimulation by the moist heat of approximately 40 degree C for 20 minutes and massage acupoints on eyebrows for eye fatigue, dry eye symptoms and symptom-induced decline of Quality of life (QoL) in VDT users.
Detailed Description
A prospective study is conducted to evaluate the effect of the steam eye mask with acupoints stimulation on eye fatigue and dry eye symptoms in VDT users. The effects and safety of the single therapy by the moist heat of approximately 40 degree C for 20 minutes with eyebrows acupoints massage for the first 3 minutes are evaluated in the single application study, and the effects and safety of the repeated therapy by the moist heat applied and massage acupoints on eyebrows once per working day for two weeks are evaluated in the repeated application study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Symptom, Eye Fatigue
Keywords
Steam Eye Mask, Acupoints Stimulation, Dry Eye Symptom, Eye Fatigue, Visual Display Terminal, Moist Heat, Massage
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Steam Eye Mask With Acupoints Stimulation
Arm Type
Experimental
Arm Description
The Steam Eye Mask with acupoints stimulation (SEM with acupoints stimulation), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air.
Also, on the eyebrow have the acupoints made by nonwoven fabric can use hands to massage.
The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes and use hands to massage the acupoints on the eyebrows for the first 3 minutes.
Arm Title
Steam Eye Mask
Arm Type
Active Comparator
Arm Description
The Steam Eye Mask (SEM), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air.
The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes.
Intervention Type
Other
Intervention Name(s)
Steam Eye Mask with acupoints stimulation
Other Intervention Name(s)
SEM with acupoints stimulation
Intervention Description
A participant needs to use SEM with acupoints stimulation once a day for 10 days and use hands to massage the acupoints on the eyebrows for the first 3 minutes, total application time at least for 20 minutes.
Intervention Type
Other
Intervention Name(s)
Steam Eye Mask
Other Intervention Name(s)
SEM
Intervention Description
A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.
Primary Outcome Measure Information:
Title
Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants.
Description
The severity of symptoms and mood state are evaluated using a VAS by each participant. A VAS is a horizontal line, 100mm in length, anchored by word descriptors at each end. Participants mark on the line the point that they feel their perception of their current state. The VAS score is determined by measuring the length from the left hand end of the line to the point that they mark. The five symptoms to be evaluated are: tiredness of eyes, dryness of eyes, grittiness of eyes, blurred vision, and ocular discomfort. Each symptom is relieved as the VAS score decreases. The mood states to be evaluated are: relaxation and comfort. Each mood state is enhanced as the VAS score increases.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
The computer visual syndrome questionnaire (CVS-Q) evaluated by participants.
Description
The computer vision syndrome questionnaire (CVS-Q) is applied to evaluate the visual health of workers exposed to the computer screen. This questionnaire consists of sixteen items with the response options of the severity (frequency and intensity) of each particular symptom and the overall symptom severity (CVS score). The score of each ocular discomfort is calculated by the frequency multiplies the intensity. The frequency for each symptom is answered by the subject as never, occasionally, and often/always which are coded as 0, 1, and 2, respectively. The intensity is defined for two options as 1 for moderate and 2 for intense, respectively. Moreover, the score obtained for each item will then be coded as 1 while the multiplied score is 1 or 2; and 2 while the multiplied score is 4. The results can be compared between different individuals or in the same individual at different times and circumstances. The higher score a subject gained, the worsen ocular condition he/she experienced.
Time Frame
19 days
Title
Dry eye questionnaire evaluated by participants.
Description
The dry eye questionnaire will be used for evaluate the dry eye symptom of each participant. This questionnaire consists of 12 typical dry-eye-related symptoms, include 1. Ocular fatigue, 2. Discharge, 3. Foreign body sensation, 4. Heavy sensation, 5. Dry sensation, 6. Uncomfortable sensation, 7. Excess tearing, 8. Blurred vision, 9. Itching, 10. Sensitivity to bright light, 11. Redness, 12. Pain. Each symptom will be evaluated from never, sometimes, often, and Constantly.
Time Frame
19 days
Title
The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants.
Description
The Dry-Eye-Related Quality of Life Score can assess various aspects of Quality of Life including its mental aspect. This questionnaire consists of 15 items related to dry eye symptoms(0 to 4, 0 as never, the less score as mild) and influence(1-4, the less score as rare) on daily life, and the overall degree of Quality of Life Score impairment is calculated as a summary score. The subject also grades the overall for the past week, including subject's eye symptoms and how they have affected subject's daily life, it will be graded from 1 to 6, the lower score means the subject is in better condition. DEQS score is decreased as Quality of Life Score is improved.
Time Frame
14 days
Title
Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.
Description
Tear Meniscus Height is observed with Oculus Keratograph 5M.
Time Frame
14 days
Title
Tear film breakup time (TBUT) evaluated by an examiner.
Description
Tear film breakup time is the parameter of tear film stability, defined as the time to initial breakup of the tear film after a blink.
Time Frame
14 days
Title
Schirmer test evaluated by an examiner.
Description
Schirmer test is an estimation of tear flow reflex by insertion of a filter paper into the conjunctival sac. This test is performed with the participants' eyes closed in 5 minutes.
Time Frame
19 days
Title
Meibomian gland expression evaluated by an examiner.
Description
Meibomian gland expression can be performed as an indicator of meibomian gland function, meibum expressibility and quality. The secretion expressed from the glands is observed with a physical force applied to the outer surface of the eyelid to determine whether a specific meibomian gland is functional and capable of providing secretion.
Time Frame
19 days
Title
Visual acuity (VA) evaluated by an examiner.
Description
The normal visual acuity is measured for both eyes separately using a Snellen chart.
Time Frame
14 days
Title
Intraocular pressure (IOP) evaluated by an examiner.
Description
The intraocular pressure is measured for both eyes separately using the tonometer.
Time Frame
14 days
Title
Ocular surface/eyelids findings diagnosed by an examiner.
Description
An ophthalmologist observes the cornea, conjunctiva, and eyelids for each participant and confirms whether there are any inflammation and hyperemia on the ocular surface or any other abnormalities on the ocular surface and eyelids before and after the application of IP.
The slit lamp is applied to evaluate the following 6 items for both eyes including 1. Lid Margin Irregularity, 2. Lid Margin Vascularity, 3. Meibomian Orifice Plugging, 4. Mucocutaneous J Retroplacement, 5. Surface Finding Cornea, and 6. Surface Finding Conjunctiva. And the clinical judgments of normal or abnormal among these items will then assess by the investigators.
Time Frame
19 days
Title
Diary reported by a participant.
Description
Participants are asked to record the time, date, place and adverse events, if there is, in a daily questionnaire after every use of IP. If there is any report of adverse events, an ophthalmologist determines the severity and the relationship of the adverse events to using IP.
Time Frame
14 days
Title
Adverse events
Description
All adverse events will be record, and the incidence rates will be calculated.
Time Frame
19 days
Title
Staining of ocular surface evaluated by an examiner
Description
Ocular surface damage is assessed by staining cornea and conjunctiva. The liquid of fluorescein is instilled by the micropipette to stain the ocular surface. The staining of ocular surface is graded on a scale of 0 to 3 on the cornea and both areas of the conjunctiva, and then summed (Total range in 0-9 points) for each eye, according to the van Bijsterveld system.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males or females aged from 20 to 69 years old (both inclusive).
Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day.
Participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire.
Participants who respond to more than 1 of 12 typical dry eye symptoms by "constantly" or "often" based on a dry eye questionnaire.
Participants are able and willing to comply with all protocol requirements and procedures.
Participants who must be capable of providing informed consent document, with one's signature.
Exclusion Criteria:
Participants with eye diseases that could affect the ocular surface (e.g. Ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases).
Participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease.
Participants with the excessive meibomian lipid secretion (seborrheic MGD).
Participants with trauma, swelling and eczema at the skin around eyes.
Participants with allergic reaction for heating, abnormality of the heat or depression of the heat.
Participants who are deemed inappropriate to participate in this study by physicians.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yih-Shiou Hwang, M.D.,Ph.D.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kao (Taiwan) Corporation
City
Hsinchu
ZIP/Postal Code
303
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects and Safety of Steam Eye Mask With Acupoints Stimulation
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