Effects and Safety of Steam Eye Mask With Acupoints Stimulation

Kao Corporation

Status: Completed

Conditions: Eye Fatigue; Dry Eye Symptom

Treatments: Other: Steam Eye Mask; Other: Steam Eye Mask with acupoints stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04584216

Kao-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Steam Eye Mask With Acupoints Stimulation

Experimental group

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.

Treatment:

Other: Steam Eye Mask with acupoints stimulation

Steam Eye Mask

Active Comparator group

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.

Treatment:

Other: Steam Eye Mask