Effects and Safety of Steam Eye Mask With Acupoints Stimulation

NCT04584216 | Completed

• 1 other identifier: Kao-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Symptom; Eye Fatigue

Keywords

Steam Eye Mask; Acupoints Stimulation; Dry Eye Symptom; Eye Fatigue; Visual Display Terminal; Moist Heat; Massage

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (13)

• The computer visual syndrome questionnaire (CVS-Q) evaluated by participants.

  19 days

• Dry eye questionnaire evaluated by participants.

  19 days

• The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants.

  14 days

• Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.

  14 days

• Tear film breakup time (TBUT) evaluated by an examiner.

  14 days

Study Arms (2)

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.

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.

Other: Steam Eye Mask

Interventions

Steam Eye Mask with acupoints stimulation OTHER

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.

Also known as: SEM with acupoints stimulation

Steam Eye Mask With Acupoints Stimulation

Steam Eye Mask OTHER

A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.

Also known as: SEM

Steam Eye Mask

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kao (Taiwan) Corporation: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Kao (Taiwan) Corporation

Hsinchu, 303, Taiwan

Location

Related Publications (22)

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  PMID: 3710486 BACKGROUND

• Uchino 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.

  PMID: 23891330 BACKGROUND

• Lin 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.

  PMID: 12799232 BACKGROUND

• Skilling 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.

  PMID: 15682562 BACKGROUND

• Odaka 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.

  PMID: 23055683 BACKGROUND

• Mori 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.

  PMID: 14636848 BACKGROUND

• Abramson 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.

  PMID: 6073416 BACKGROUND

• Geerling 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.

  PMID: 21450919 BACKGROUND

• Segui 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.

  PMID: 25744132 BACKGROUND

• Toda 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.

  PMID: 8362634 BACKGROUND

• Sakane 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.

  PMID: 23949096 BACKGROUND

• The 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.

  PMID: 17508117 BACKGROUND

• The 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.

  PMID: 17508116 BACKGROUND

• Methodologies 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.

  PMID: 17508118 BACKGROUND

• Shimazaki 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.

  PMID: 7575257 BACKGROUND

• Bron AJ, Benjamin L, Snibson GR. Meibomian gland disease. Classification and grading of lid changes. Eye (Lond). 1991;5 ( Pt 4):395-411. doi: 10.1038/eye.1991.65.

  PMID: 1743355 BACKGROUND

• Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, Jung SY, Kim AR, Jung HJ, Choi JB, Hong KE, Lee SD, Choi SM. Acupuncture for the treatment of dry eye: a multicenter randomised controlled trial with active comparison intervention (artificial teardrops). PLoS One. 2012;7(5):e36638. doi: 10.1371/journal.pone.0036638. Epub 2012 May 17.

  PMID: 22615787 BACKGROUND

• Murata A., Uetake A., Ostuka M., Takasawa Y., Proposal of an index to evaluate visual fatigue induced during visual display terminal tasks. International Journal of Human-Computer Interaction 13(3): 305-321, 2001.

  BACKGROUND

• Wu H.C., Chiu M.C., Jian J.H., Evaluation of Four Eyestrain Recovery Methods for Visual Display Terminal Workers, Communications in Computer and Information Science 617: 536-541, 2016.

  BACKGROUND

• Nagashima Y., Effect of autonomic nervous activity of the application of heat- and steam- generating sheets to the eyes [in Japanese]. Jpn J Auton Nervous Syst, 43 260-268, 2006.

  BACKGROUND

• Ochiai R., Moist heat stimulation influence on electroencephalograms and the autonomic nervous system [in Japanese]. Jpn J Auton Nervous Syst, 38: 450-454, 2001.

  BACKGROUND

• Yang L, Yang Z, Yu H, Song H. Acupuncture therapy is more effective than artificial tears for dry eye syndrome: evidence based on a meta-analysis. Evid Based Complement Alternat Med. 2015;2015:143858. doi: 10.1155/2015/143858. Epub 2015 Apr 16.

  PMID: 25960747 BACKGROUND

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Yih-Shiou Hwang, M.D.,Ph.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 12, 2020
• Study Start: May 9, 2020
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)