Dry Eye SymptomNCT04584216
Effects and Safety of Steam Eye Mask With Acupoints Stimulation
A study testing Steam Eye Mask with acupoints stimulation and Steam Eye Mask in people with Dry Eye Symptom and Eye Fatigue, run by Kao (Taiwan) Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Symptom, Eye Fatigue
- What is being tested?
- Steam Eye Mask with acupoints stimulation and Steam Eye Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2020to 16 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects and Safety by the Steam Eye Mask With Acupoints Stimulation for VDT User
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.
Read the 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.
- Conditions
- Dry Eye Symptom, Eye Fatigue
- Being tested
- Steam Eye Mask with acupoints stimulation, Steam Eye Mask
- Keywords
- Steam Eye Mask, Acupoints Stimulation, Dry Eye Symptom, Eye Fatigue, Visual Display Terminal, Moist Heat, Massage
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steam Eye Mask with acupoints stimulationOther
Also called SEM with acupoints stimulation
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.
Steam Eye MaskOther
Also called SEM
A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Steam Eye Mask With Acupoints Stimulation | Experimental | 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. Receives: Other: Steam Eye Mask with acupoints stimulation |
| Steam Eye Mask | Active comparator | 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. Receives: Other: Steam Eye Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (13)
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.
Measured: 19 days
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.
Measured: 19 days
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.
Measured: 14 days
Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.
Tear Meniscus Height is observed with Oculus Keratograph 5M.
Measured: 14 days
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.
Measured: 14 days
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.
Measured: 19 days
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.
Measured: 19 days
Visual acuity (VA) evaluated by an examiner.
The normal visual acuity is measured for both eyes separately using a Snellen chart.
Measured: 14 days
Intraocular pressure (IOP) evaluated by an examiner.
The intraocular pressure is measured for both eyes separately using the tonometer.
Measured: 14 days
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.
Measured: 19 days
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.
Measured: 14 days
Adverse events
All adverse events will be record, and the incidence rates will be calculated.
Measured: 19 days
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start9 May 2020
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kao (Taiwan) Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Yih-Shiou Hwang, M.D.,Ph.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584216
- Sponsor's protocol ID
- Kao-001
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cushman WH. Reading from microfiche, a VDT, and the printed page: subjective fatigue and performance. Hum Factors. 1986 Feb;28(1):63-73. doi: 10.1177/001872088602800107. No abstract available.
PubMed 3710486Uchino M, Yokoi N, Uchino Y, Dogru M, Kawashima M, Komuro A, Sonomura Y, Kato H, Kinoshita S, Schaumberg DA, Tsubota K. Prevalence of dry eye disease and its risk factors in visual display terminal users: the Osaka study. Am J Ophthalmol. 2013 Oct;156(4):759-66. doi: 10.1016/j.ajo.2013.05.040. Epub 2013 Jul 24.
PubMed 23891330Lin PY, Tsai SY, Cheng CY, Liu JH, Chou P, Hsu WM. Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2003 Jun;110(6):1096-101. doi: 10.1016/S0161-6420(03)00262-8.
PubMed 12799232Skilling FC Jr, Weaver TA, Kato KP, Ford JG, Dussia EM. Effects of two eye drop products on computer users with subjective ocular discomfort. Optometry. 2005 Jan;76(1):47-54. doi: 10.1016/s1529-1839(05)70254-2.
PubMed 15682562Odaka A, Toshida H, Ohta T, Tabuchi N, Koike D, Suto C, Murakami A. Efficacy of retinol palmitate eye drops for dry eye in rabbits with lacrimal gland resection. Clin Ophthalmol. 2012;6:1585-93. doi: 10.2147/OPTH.S35584. Epub 2012 Oct 1.
PubMed 23055683Mori A, Shimazaki J, Shimmura S, Fujishima H, Oguchi Y, Tsubota K. Disposable eyelid-warming device for the treatment of meibomian gland dysfunction. Jpn J Ophthalmol. 2003 Nov-Dec;47(6):578-86. doi: 10.1016/s0021-5155(03)00142-4.
PubMed 14636848Abramson DI, Tuck S Jr, Lee SW, Richardson G, Levin M, Buso E. Comparison of wet and dry heat in raising temperature of tissues. Arch Phys Med Rehabil. 1967 Dec;48(12):654-61. No abstract available.
PubMed 6073416Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.
PubMed 21450919Segui Mdel M, Cabrero-Garcia J, Crespo A, Verdu J, Ronda E. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol. 2015 Jun;68(6):662-73. doi: 10.1016/j.jclinepi.2015.01.015. Epub 2015 Jan 28.
PubMed 25744132Toda I, Fujishima H, Tsubota K. Ocular fatigue is the major symptom of dry eye. Acta Ophthalmol (Copenh). 1993 Jun;71(3):347-52. doi: 10.1111/j.1755-3768.1993.tb07146.x.
PubMed 8362634Sakane Y, Yamaguchi M, Yokoi N, Uchino M, Dogru M, Oishi T, Ohashi Y, Ohashi Y. Development and validation of the Dry Eye-Related Quality-of-Life Score questionnaire. JAMA Ophthalmol. 2013 Oct;131(10):1331-8. doi: 10.1001/jamaophthalmol.2013.4503.
PubMed 23949096The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):93-107. doi: 10.1016/s1542-0124(12)70082-4.
PubMed 17508117The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
PubMed 17508116Methodologies to diagnose and monitor dry eye disease: report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):108-52. doi: 10.1016/s1542-0124(12)70083-6.
PubMed 17508118Shimazaki J, Sakata M, Tsubota K. Ocular surface changes and discomfort in patients with meibomian gland dysfunction. Arch Ophthalmol. 1995 Oct;113(10):1266-70. doi: 10.1001/archopht.1995.01100100054027.
PubMed 7575257
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects and Safety by the Steam Eye Mask With Acupoints Stimulation for VDT User
- ClinicalTrials.gov ID
- NCT04584216
- Acronym / sponsor ID
- Kao-001
- Conditions
- Dry Eye Symptom, Eye Fatigue
- Keywords
- Steam Eye Mask, Acupoints Stimulation, Dry Eye Symptom, Eye Fatigue, Visual Display Terminal, Moist Heat, Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kao (Taiwan) CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 9 May 2020 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steam Eye Mask With Acupoints Stimulation | Experimental | Other: Steam Eye Mask with acupoints stimulationThe 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. |
| Steam Eye Mask | Active comparator | Other: Steam Eye MaskThe 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. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steam Eye Mask with acupoints stimulationAlso: SEM with acupoints stimulationA 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. | Other | Steam Eye Mask With Acupoints Stimulation |
| Steam Eye MaskAlso: SEMA participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes. | Other | Steam Eye Mask |
Primary outcome
Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants.
Time frame: 14 days
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.
13 secondary outcomes
The computer visual syndrome questionnaire (CVS-Q) evaluated by participants.
Time frame: 19 days
Dry eye questionnaire evaluated by participants.
Time frame: 19 days
The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants.
Time frame: 14 days
Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.
Time frame: 14 days
Tear film breakup time (TBUT) evaluated by an examiner.
Time frame: 14 days
Schirmer test evaluated by an examiner.
Time frame: 19 days
Meibomian gland expression evaluated by an examiner.
Time frame: 19 days
Visual acuity (VA) evaluated by an examiner.
Time frame: 14 days
Intraocular pressure (IOP) evaluated by an examiner.
Time frame: 14 days
Ocular surface/eyelids findings diagnosed by an examiner.
Time frame: 19 days
Diary reported by a participant.
Time frame: 14 days
Adverse events
Time frame: 19 days
Staining of ocular surface evaluated by an examiner
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 3710486Cushman WH. Reading from microfiche, a VDT, and the printed page: subjective fatigue and performance. Hum Factors. 1986 Feb;28(1):63-73. doi: 10.1177/001872088602800107. No abstract available.
- Background: PubMed 23891330Uchino M, Yokoi N, Uchino Y, Dogru M, Kawashima M, Komuro A, Sonomura Y, Kato H, Kinoshita S, Schaumberg DA, Tsubota K. Prevalence of dry eye disease and its risk factors in visual display terminal users: the Osaka study. Am J Ophthalmol. 2013 Oct;156(4):759-66. doi: 10.1016/j.ajo.2013.05.040. Epub 2013 Jul 24.
- Background: PubMed 12799232Lin PY, Tsai SY, Cheng CY, Liu JH, Chou P, Hsu WM. Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2003 Jun;110(6):1096-101. doi: 10.1016/S0161-6420(03)00262-8.
- Background: PubMed 15682562Skilling FC Jr, Weaver TA, Kato KP, Ford JG, Dussia EM. Effects of two eye drop products on computer users with subjective ocular discomfort. Optometry. 2005 Jan;76(1):47-54. doi: 10.1016/s1529-1839(05)70254-2.
- Background: PubMed 23055683Odaka A, Toshida H, Ohta T, Tabuchi N, Koike D, Suto C, Murakami A. Efficacy of retinol palmitate eye drops for dry eye in rabbits with lacrimal gland resection. Clin Ophthalmol. 2012;6:1585-93. doi: 10.2147/OPTH.S35584. Epub 2012 Oct 1.
- Background: PubMed 14636848Mori A, Shimazaki J, Shimmura S, Fujishima H, Oguchi Y, Tsubota K. Disposable eyelid-warming device for the treatment of meibomian gland dysfunction. Jpn J Ophthalmol. 2003 Nov-Dec;47(6):578-86. doi: 10.1016/s0021-5155(03)00142-4.
- Background: PubMed 6073416Abramson DI, Tuck S Jr, Lee SW, Richardson G, Levin M, Buso E. Comparison of wet and dry heat in raising temperature of tissues. Arch Phys Med Rehabil. 1967 Dec;48(12):654-61. No abstract available.
- Background: PubMed 21450919Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.
- Background: PubMed 25744132Segui Mdel M, Cabrero-Garcia J, Crespo A, Verdu J, Ronda E. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol. 2015 Jun;68(6):662-73. doi: 10.1016/j.jclinepi.2015.01.015. Epub 2015 Jan 28.
- Background: PubMed 8362634Toda I, Fujishima H, Tsubota K. Ocular fatigue is the major symptom of dry eye. Acta Ophthalmol (Copenh). 1993 Jun;71(3):347-52. doi: 10.1111/j.1755-3768.1993.tb07146.x.
- Background: PubMed 23949096Sakane Y, Yamaguchi M, Yokoi N, Uchino M, Dogru M, Oishi T, Ohashi Y, Ohashi Y. Development and validation of the Dry Eye-Related Quality-of-Life Score questionnaire. JAMA Ophthalmol. 2013 Oct;131(10):1331-8. doi: 10.1001/jamaophthalmol.2013.4503.
- Background: PubMed 17508117The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):93-107. doi: 10.1016/s1542-0124(12)70082-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yih-Shiou Hwang, M.D.,Ph.D. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steam Eye Mask with acupoints stimulation and Steam Eye Mask in people with Dry Eye Symptom and Eye Fatigue, run by Kao (Taiwan) Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584216, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.