Effects and Safety of Steam Eye Mask With Acupoints Stimulation

October 6, 2020 updated by: Kao (Taiwan) Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 303
        • Kao (Taiwan) Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females aged from 20 to 69 years old (both inclusive).
  2. Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day.
  3. 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.
  4. Participants who respond to more than 1 of 12 typical dry eye symptoms by "constantly" or "often" based on a dry eye questionnaire.
  5. Participants are able and willing to comply with all protocol requirements and procedures.
  6. Participants who must be capable of providing informed consent document, with one's signature.

Exclusion Criteria:

  1. Participants with eye diseases that could affect the ocular surface (e.g. Ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases).
  2. 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.
  3. Participants with the excessive meibomian lipid secretion (seborrheic MGD).
  4. Participants with trauma, swelling and eczema at the skin around eyes.
  5. Participants with allergic reaction for heating, abnormality of the heat or depression of the heat.
  6. Participants who are deemed inappropriate to participate in this study by physicians.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Steam Eye Mask With Acupoints Stimulation

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
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.
Other Names:
  • SEM with acupoints stimulation
ACTIVE_COMPARATOR: Steam Eye Mask

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The computer visual syndrome questionnaire (CVS-Q) evaluated by participants.
Time Frame: 19 days
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.
19 days
Dry eye questionnaire evaluated by participants.
Time Frame: 19 days
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.
19 days
The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants.
Time Frame: 14 days
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.
14 days
Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.
Time Frame: 14 days
Tear Meniscus Height is observed with Oculus Keratograph 5M.
14 days
Tear film breakup time (TBUT) evaluated by an examiner.
Time Frame: 14 days
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.
14 days
Schirmer test evaluated by an examiner.
Time Frame: 19 days
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.
19 days
Meibomian gland expression evaluated by an examiner.
Time Frame: 19 days
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.
19 days
Visual acuity (VA) evaluated by an examiner.
Time Frame: 14 days
The normal visual acuity is measured for both eyes separately using a Snellen chart.
14 days
Intraocular pressure (IOP) evaluated by an examiner.
Time Frame: 14 days
The intraocular pressure is measured for both eyes separately using the tonometer.
14 days
Ocular surface/eyelids findings diagnosed by an examiner.
Time Frame: 19 days

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.
19 days
Diary reported by a participant.
Time Frame: 14 days
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.
14 days
Adverse events
Time Frame: 19 days
All adverse events will be record, and the incidence rates will be calculated.
19 days
Staining of ocular surface evaluated by an examiner
Time Frame: 14 days
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kao (Taiwan) Corporation

Collaborators

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yih-Shiou Hwang, M.D.,Ph.D., Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 9, 2020

Primary Completion (ACTUAL)

June 16, 2020

Study Completion (ACTUAL)

June 16, 2020

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (ACTUAL)

October 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kao-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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