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Completed

NCT Number: NCT06326931

Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jacksoneye

Lake Villa, Illinois, 60046, United States

About this study

This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD).

Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score >23, total meibomian gland secretion (MGS) score < or =12 in the lower lid of each eye, and tear break-up time (TBUT) < 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • history of self-reported dry eye symptoms for 3 months prior to study enrollment
  • baseline OSDI score of 23 or greater (
  • MGS score of 12 ior less in the lower eyelid of each eye
  • TBUT <10 seconds
  • willing and able to abstain from using any new ocular lubricants

Exclusion criteria

  • diagnosis of thyroid dysfunction or rheumatoid arthritis
  • history of laser-assisted in situ keratomileusis (LASIK); any other ocular surgery within the previous 12 months
  • abnormal lid anatomy or active lid lesions
  • use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month
  • active ocular infection
  • pterygium
  • planned use of contact lenses, topical antibiotics, steroids, or immunomodulating drops
  • CDVA worse than 0.2 logMAR

Treatment and study plan

thermal pulsation

Device

Single, in-office bilateral treatment with Systane iLux thermal pulsation

Other names: Systane iLux

warm compress

Other

Twice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks

Other names: Bruder mask

Primary outcomes

  1. Change in MGS score for the worse eye

    Time frame: baseline to Week 8

    Change in MGS score for the worse eye

Secondary outcomes

  1. Change in MGS score for the worse eye

    Time frame: baseline to Week 2

    Change in MGS score for the worse eye

  2. Change in OSDI score

    Time frame: Baseline to Week 2

    Change in OSDI score

  3. Change in OSDI score

    Time frame: Baseline to Week 8

    Change in OSDI score

  4. Incidence of adverse events

    Time frame: 8 weeks

    Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Jacksoneye

Other

Registry information

Official study title

A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

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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