Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

Phase 4

Completed

• Conditions: Meibomian Gland Dysfunction
• Interventions: Device: thermal pulsation; Other: warm compress

• Registration Number: NCT06326931
• Lead Sponsor: Jacksoneye

Brief Summary

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.

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 Timeline

• Study Start: 2022-06-24
• Primary Completion: 2023-06-22
• Study Completion: 2023-06-22
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermal pulsation group	thermal pulsation	Group treated in both eyes with a single Systane iLux thermal pulsation treatment
Warm compress group	warm compress	Group treated in both eyes with 10 minute application of Bruder warm compress mask, twice daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in MGS score for the worse eye	baseline to Week 8	Change in MGS score for the worse eye

Secondary Outcome Measures

Name	Time	Method
Change in MGS score for the worse eye	baseline to Week 2	Change in MGS score for the worse eye
Incidence of adverse events	8 weeks	Incidence of adverse events
Change in OSDI score	Baseline to Week 8	Change in OSDI score

Trial Locations

Locations (1)

Jacksoneye; 🇺🇸 Lake Villa, Illinois, United States