Clinical trial NCT04584216: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Symptom
Eye Fatigue
Keywords: Steam Eye Mask
Acupoints Stimulation
Dry Eye Symptom
Eye Fatigue
Visual Display Terminal
Moist Heat
Massage
Lead sponsor: Kao (Taiwan) Corporation
Sponsor class: INDUSTRY
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2020-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants.
timeFrame: 14 days
Secondary outcomes:
measure: The computer visual syndrome questionnaire (CVS-Q) evaluated by participants.
timeFrame: 19 days
measure: Dry eye questionnaire evaluated by participants.
timeFrame: 19 days
measure: The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants.
timeFrame: 14 days
measure: Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.
timeFrame: 14 days
measure: Tear film breakup time (TBUT) evaluated by an examiner.
timeFrame: 14 days
measure: Schirmer test evaluated by an examiner.
timeFrame: 19 days
measure: Meibomian gland expression evaluated by an examiner.
timeFrame: 19 days
measure: Visual acuity (VA) evaluated by an examiner.
timeFrame: 14 days
measure: Intraocular pressure (IOP) evaluated by an examiner.
timeFrame: 14 days
measure: Ocular surface/eyelids findings diagnosed by an examiner.
timeFrame: 19 days
measure: Diary reported by a participant.
timeFrame: 14 days
measure: Adverse events
timeFrame: 19 days
measure: Staining of ocular surface evaluated by an examiner
timeFrame: 14 days
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Kao (Taiwan) Corporation
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yih-Shiou Hwang, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
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