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NCT Number: NCT07060131

Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome

Dry eye disease (DED) is a multifactorial ocular surface condition characterized by instability of the tear film. DED is common in ophthalmic and optometric clinical practice, and meibomian gland dysfunction (MGD) has been identified as a major cause of evaporative DED. The use of heated eye mask is a common recommendation in the treatment of MGD, aiming to adequately heat the meibum to increase its liquefaction and flow. Several products are available for this purpose (e.g., Bruder Moist Heat Eye Compress [Bruder Healthcare Company], EyeGiene® [Eyedetec Medical], Blepha EyeBag® [formerly MGDRx EyeBag, Théa Pharmaceuticals Ltd], Blephasteam® [Théa Pharmaceuticals Ltd]).

This study employs far-infrared eye masks on the acupoints around the eyes, including Jingming, Taiyang, Sibai, Tongziliao, and Si Zhu Kong to assess whether there is an improvement in the symptomatic indicators of dry eye disease.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, North Dist, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

*Clinical diagnosis of Dry Eye Disease by Ocular Surface Disease Index (OSDI) ≥ 13 and NIBUT <10 seconds.

Exclusion criteria

  • Eye inflammation
  • Eyelid malposition, such as entropion, ectropion, and upper eyelid ptosis
  • Recent eye surgery (within 3 months)
  • Risks of retinal detachment such as high myopia, lattice degeneration, and retinal holes
  • Use anti-inflammatory eye drops (topical steroids or cyclosporine) within 1 month

Treatment and study plan

Far Infrared Eye Masks

Device

Using far-infrared eye masks on the acupoints around the eyes, including Jingming, Taiyang, Sibai, Tongziliao, and Si Zhu Kong to assess whether there is an improvement in the symptomatic indicators of dry eye disease.

Primary outcomes

  1. Two-tailed Paired T-test of Persons with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _OSDI

    Time frame: 2 years

    OSDI is collected in scores All the data mentioned above will be collected before and after treatment one month later. They will be compared with two-tailed paired t-test separately. P < 0.05 was considered statistically significant.

  2. Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _NIBUT(non-invasive break-up time)

    Time frame: 2 years

    NIBUT(non-invasive break-up time) recorded in sec will be collected before and after treatment 30 mins and one month later. They will be compared with two-tailed paired t-test separately. P < 0.05 was considered statistically significant.

  3. Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Meibomian Gland Loss

    Time frame: 2 years

    Meibomian Gland Loss in percentage will be collected before and after treatment 30 mins and one month later . They will be compared with two-tailed paired t-test separately. P < 0.05 was considered statistically significant.

  4. Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Schirmer test

    Time frame: 2 years

    Description: Schirmer test in mm. All the data mentioned above will be collected before and after treatment 30 mins and one month later. They will be compared with two-tailed paired t-test separately. P < 0.05 was considered statistically significant.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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