Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

NCT06326931 | Completed Phase 4 FDA Device

• 1 other identifier: JE001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in MGS score for the worse eye

  Change in MGS score for the worse eye

  baseline to Week 8

Secondary Outcomes (4)

• Change in MGS score for the worse eye

  baseline to Week 2

• Change in OSDI score

  Baseline to Week 2

• Change in OSDI score

  Baseline to Week 8

• Incidence of adverse events

  8 weeks

Study Arms (2)

Thermal pulsation group

EXPERIMENTAL

Group treated in both eyes with a single Systane iLux thermal pulsation treatment

Device: thermal pulsation

Warm compress group

ACTIVE COMPARATOR

Group treated in both eyes with 10 minute application of Bruder warm compress mask, twice daily for 8 weeks

Other: warm compress

Interventions

thermal pulsation DEVICE

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

Also known as: Systane iLux

Thermal pulsation group

warm compress OTHER

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

Also known as: Bruder mask

Warm compress group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacksoneye: lead

Study Sites (1)

Jacksoneye

Lake Villa, Illinois, 60046, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Melissa Bollinger, OD, FAAO

  Jacksoneye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinician evaluating MGS score was masked to subject treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Prospective, randomized, controlled clinical trial

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 22, 2024
• Study Start: June 24, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)