Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

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

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Device: thermal pulsation; Other: warm compress

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Lake Villa, Illinois, United States, 60046
      • JacksonEye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal pulsation group; Group treated in both eyes with a single Systane iLux thermal pulsation treatment	Device: thermal pulsation; Single, in-office bilateral treatment with Systane iLux thermal pulsation; Other Names: Systane iLux
Active Comparator: Warm compress group; Group treated in both eyes with 10 minute application of Bruder warm compress mask, twice daily for 8 weeks	Other: warm compress; Twice daily, 10-minute at-home treatment with Bruder warm compress mask for 8 weeks; Other Names: Bruder mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MGS score for the worse eye	Change in MGS score for the worse eye	baseline to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MGS score for the worse eye	Change in MGS score for the worse eye	baseline to Week 2
Change in OSDI score	Change in OSDI score	Baseline to Week 2
Change in OSDI score	Change in OSDI score	Baseline to Week 8
Incidence of adverse events	Incidence of adverse events	8 weeks

Collaborators and Investigators

• Sponsor: Jacksoneye
• Investigators: Principal Investigator: Melissa Bollinger, OD, FAAO, JacksonEye

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: JE001

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: Yes
• product manufactured in and exported from the U.S.: Yes