Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06326931
• Other study ID #: JE001
• Status: Completed
• Phase: Phase 4
• Start date: June 24, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: March 2024
• Source: Jacksoneye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

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

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

Locations

Country	Name	City	State
United States	Jacksoneye	Lake Villa	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Jacksoneye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MGS score for the worse eye	Change in MGS score for the worse eye	baseline to Week 8
Secondary	Change in MGS score for the worse eye	Change in MGS score for the worse eye	baseline to Week 2
Secondary	Change in OSDI score	Change in OSDI score	Baseline to Week 2
Secondary	Change in OSDI score	Change in OSDI score	Baseline to Week 8
Secondary	Incidence of adverse events	Incidence of adverse events	8 weeks